2013 biomedicine and biomaterials catalogue

Woodhead Publishing

Biomedicine and Biomaterials2013 Catalogue

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Contents

BiomedicineBioengineering, biotechnology

Bioinformatics, computing and life sciences

Genetics and genomics

Intellectual property, regulation

Life science, molecular and cellular biology

Management and business

Manufacturing and processing

Medical science and technology, cancer research

Nanoscience and technology in medicine

Pharmaceutical science/technology, drug delivery

Regenerative medicine

Stem cell sciences

BiomaterialsApplications

Clinical techniques

Materials

Medical textiles

Technologies and performance

Title index

Author index

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Denotes titles published from January 2012 onwards.

Available / will be available on Woodhead Publishing Online

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BIOENGINEERING, BIOTECHNOLOGY

From plant genomics to plant biotechnologyP Poltronieri, Italian National Research Council, Italy, N Burbulis, Aleksandr Stulginskis University, Lithuania and C Fogher, Catholic University, Italy

Woodhead Publishing Series in Biomedicine No. 53

From plant genomics to plant biotechnology reviews the recent advancements in the post-genomic era, discussing how different varieties respond to abiotic and biotic stresses, understanding the epigenetic control and epigenetic memory (RNAs, DNA methylation, histone modifications and polycomb complexes), the roles of non-coding RNAs, applicative uses of RNA silencing and RNA interference in plant physiology and in experimental transgenics and plants modified to specific aims (biofuels, production of high-value pharmaceutical proteins in plants, abiotic stress resistant wood trees and ornamental plants). In the forthcoming years these advancements will support the production of plant varieties better suited to resist biotic and abiotic stresses, for food and non-food applications.

CONTENTSIntroduction and overview on EU plant research networks; Approaches to plant microRNAs - identification of microRNAs and their targets using bioinformatic tools; Approaches to understanding the epigenetic control of chromatin states by the polycomb complexes; Approaches to SuperSAGE and Tag-DNA microarrays to chickpea studies - differential responses during salt stress in susceptible and resistant varieties; GrainLegumes Project - improvements of legume varieties and their exploitation; Application of doubled haploid technology in breeding of Brassica napus; Phenotyping platforms and field phenotyping equations for phenomics analysis and breeding progress; Approaches to functional genomics from strawberry and potato genome sequences; Approaches to pine tree functional genomics from the pine tree genome sequencing; Approaches in peach transcriptomics, tissue specific differential expression and peach phenotyping; Approaches in grapevine genomics to understand the environmental responses in grape varieties and improve disease resistance; Approaches to plant research and plant biotechnology for pharma and biofuel sectors; Conclusions – outlook.

280 pages 234 x 156mm (6 x 9) hardback Q1 2014ISBN: 978 1 907568 29 9 E-ISBN: 978 1 908818 47 8

Approx. £99.00/US$170.00/€120.00www.woodheadpublishing.com/9781907568299

An introduction to biotechnologyThe science, technology and medical applicationsW T Godbey, Tulane University, USA


An introduction to biotechnology is a biotechnology textbook aimed at undergraduates. It covers the basics of cell biology, biochemistry and molecular biology, and introduces laboratory techniques specific to the technologies addressed in the book. It addresses specific biotechnologies at both the theoretical and applications levels.

CONTENTSPart 1 The cell: Plasma membrane, phospholipids, proteins, cholesterol: Prokaryotic outer barriers, cell wall (NAMs, NAGs, crosslinking); The cytoplasm, more proteins: Enzymes (enzymes are catalysts, enzymes depend on proper protein folding, enzymes used in science, enzymes used in industry; The nucleus, organization of the genome (chromosomes, DNA fibers, nucleosomes, DNA strands, RNA); Prokaryotic genome organization, circular genome, attached to inner plasma membrane; The central dogma, transcription (mRNA); The life of a cell, the cell cycle (synthesis (S) phase, mitosis (M), gap phases, cell cycle control). Part 2 Biotechnology: Applications to and of the cell; Genetic engineering, genes (exons, introns, promoters, enhancers); Gene delivery models, viral (adenovirus, adeno-associated virus, herpesvirus, lentivirus/retrovirus); Gene delivery cargo, DNA, RNA, siRNA; Fluorescence, quantum yield, Stokes’ shift, brightness; Recombinant Proteins; Biofuels, from cellulose degradation (biochemistry of cellulose); Stem cells, cells with potential (totipotent, pluripotent, multipotent); Transgenics; Cloning.



Electroporation-based therapies for cancerFrom basics to clinical applicationsEdited by R Sundararajan, Purdue University, USA


Electroporation-based therapies for cancer provides a comprehensive overview of electroporation-based clinical studies in the hospitals for various cancer treatments including melanomas, head and neck cancers, chest wall breast carcinomas and colorectal cancers, and also looks at research studies in the lab using cell lines, primary cells, and animals.

CONTENTSClinical electro-chemo-therapy for advanced superficial melanoma; Effective electro-chemo-therapy for chest wall recurrence of breast carcinoma; Electrochemotherapy - aspects of clinical experience; Low and high voltage electro-chemo-therapy for breast cancer: An in vitro model study; Electrically-enhanced proliferation control of cancer-stem-cells-like adult human mesenchymal stem cells: A novel modality of treatment; Why electroporation is a useful technique for cancer treatments; Electro-endocrine therapy for breast cancer; Electroporation of cervical and leukemia cancer cells; Targeted delivery of siRNA and other difficult to transfect molecules using electroporation; Nanosecond, low voltage pulses for electro-endocrine therapy; Low and high voltage electroporation of ovarian cancer cells; Irreversible electroporation; Electric field distribution study of malignant tumors.



MATLAB® in bioscience and biotechnologyL Burstein, Technion, Haifa University, Israel


MATLAB® in bioscience and biotechnology presents an introductory Matlab course oriented towards various collaborative areas of biotechnology and bioscience. It concentrates on Matlab fundamentals and gives examples of its application to a wide range of current bioengineering problems in computational biology, molecular biology, bio-kinetics, biomedicine, bioinformatics, and biotechnology. In this book, Matlab is presented with examples and applications to various school-level and advanced bioengineering problems.

CONTENTSMATLAB® basics; MATLAB® graphics; Script, function files and some useful MATLAB® functions; Ordinary and partial differential equation solvers; Bioinformatics tool for sequence analysis.

248 pages 234 x 156mm (6 x 9) hardback 2011ISBN: 978 1 907568 04 6 E-ISBN: 978 1 908818 03 4

£85.00/US$145.00/€100.00www.woodheadpublishing.com/9781907568046

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A biotech manager’s handbookA practical guideEdited by M O’Neill, Eolas Biosciences Limited and M M Hopkins, University of Sussex, UK


A biotech manager’s handbook lays out - in a simple straightforward manner - for the manager or would-be entrepreneur, the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts with outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur.

CONTENTSThe bioscience sector: Challenges and opportunities; Academic innovation: So you want to be a bio-entrepreneur? Leadership and you; Managing self, situations and stress; It’s all in the plan; Exploring funding routes for therapeutics firms; Raising funds and managing finances; Introduction to intellectual property; Managing projects and portfolios in R&D: Why and how; Successful registration of new therapies; Clinical trials: Design and practice; Business development: Starting out; Business development: To the deal and beyond; Conclusions and final thoughts.



BIOINFORMATICS, COMPUTING AND LIFE SCIENCES

Bioinformatics for computer scienceFoundations in molecular biologyK Revett, University of Westminster, UK


This key book serves as a comprehensive introduction to the required molecular biology background necessary for non-biologists - especially computer scientists - to engage in bioinformatics-based research programs. Bioinformatics for computer science bridges the gap between the underlying biological questions and the methodologies employed in bioinformatics. The goal is to provide both the biologist with some of the required computational knowledge, and the non-biologist with the necessary understanding of the required concepts to allow them to develop more domain-specific approaches to address key questions in bioinformatics.

CONTENTSSection 1 the biological perspective: An introduction to molecular biology; Nucleic acids; Proteins; Carbohydrates. Section 2 The computational perspective: Sequence analysis; The relationship between structure and function. Section 3 The future in bioinformatics: How can we integrate the ‘omics’?

270 pages 234 x 156mm (6 x 9) hardback Q1 2014ISBN: 978 1 907568 32 9 E-ISBN: 978 1 908818 46 1Approx. £99.00/US$170.00/€120.00

paperback ISBN: 978 1 907568 22 0


Computational methods for finding inferential bases in molecular geneticsQ-N Tran, Lamar (Texas State) University, USA


Computational methods for finding inferential bases in molecular genetics covers computational methods for selecting relevant biomolecules such as genes and protein kinases with an emphasis on a new method.

CONTENTSPart 1 Introduction: Introduction. Part 2 Computational methods for gene selection: Preliminaries for gene selection and classification methods; Gene selection using Gini ratios and Loren curves; Experimentation. Part 3 Computational methods for quantitative analysis of kinase inhibitor selectivity. Preliminaries for kinase inhibitors and their selectivity; Kinase selection for selectivity analysis; Experimentation. Part 4 Software development: Implementation; Practical usage of the software.



In silico protein designC M Frenz, The New York City College of Technology (CUNY), USA


In silico protein design covers the computational techniques that are most frequently utilized by protein engineers. The advent of biotechnology has made proteins play an increasingly important role as medicinal therapeutics, catalysts in the chemical process industries, and numerous other applications. Many of these applications are dependent on the field of protein engineering to either modify existing proteins to alter/enhance their functionality or to create novel proteins capable of novel functionality. In the last decade, the rapid advances made by the computer industry have allowed for the creation of computer systems capable of modelling proteins to become relatively commonplace. As such, there has been a marked increase in the use of computational methods to engineer proteins.

CONTENTSPart 1 Fundamentals: Introduction to proteins; Introduction to computer modelling; Protein structure prediction. Part 2 Modifying existing proteins: Modifying stability; Modifying activity; Altering protein pH profiles - pKa prediction; altering protein pKa’s. Part 3 Design of novel proteins: Engineering novel proteins.



Bioinformatics for biomedical science and clinical applicationsK-H Liang, LinKo Medical Center, Chang Gung Memorial Hospital, Taiwan R.O.C.


Contemporary biomedical and clinical research are undergoing constant development thanks to the rapid advancement of various high throughput technologies at the DNA, RNA and protein levels. These technologies can generate vast amounts of raw data, making bioinformatics methodologies essential in their use for basic biomedical and clinical applications. Bioinformatics for biomedical science and clinical applications demonstrates what these cutting-edge technologies can do and examines how to design an appropriate study, including how to deal with data and address specific clinical questions.

CONTENTSGeneral introduction: From uncertainty to adaptivity; Transcriptomics; Systems biomedical science; Clinical developments; Concluding remarks.



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Computer-aided vaccine designT J Chuan, A*STAR Institute for Infocomm Research, Singapore and S Ranganathan, Macquarie University, Australia


Computational pre-screening of antigens is now routinely applied to the discovery of vaccine candidates. Computer-aided vaccine design is a comprehensive introduction to this exciting field of study. The book is intended to be a textbook for researchers and for courses in bioinformatics, as well as a laboratory reference guide. It is written mainly for biologists who want to understand the current methods of computer-aided vaccine design. The contents are designed to help biologists appreciate the underlying concepts and algorithms used, as well as limitations of the methods and strategies for their use. The book is of interest to computational biologists who would like to understand more about the biological concepts related to the field of computational immunology.

CONTENTSComputer-aided vaccine design: Its nature and scope; Immunological databases; Infectious disease informatics; T cell vaccine design; B cell vaccine design; Vaccine safety and quality assessments; Adjuvant informatics.



Deterministic versus stochastic modelling in biochemistry and systems biologyP Lecca, The Microsoft Research – University of Trento, COSBI, Italy, I Laurenzi, ExxonMobil, USA and F Jordan, The Microsoft Research – University of Trento, COSBI, Italy


Deterministic versus stochastic modelling in biochemistry and systems biology introduces and critically reviews the deterministic and stochastic foundations of biochemical kinetics, covering applied stochastic process theory for application in the field of modelling and simulation of biological processes at the molecular scale.

CONTENTSDeterministic chemical kinetics; The stochastic approach to biochemical kinetics; The exact stochastic simulation algorithms; Modelling in systems biology; The structure of biochemical models; Reaction-diffusion systems; KInfer: A tool for model calibration; Modelling living systems with BlenX; Simulation of ecodynamics: Key nodes in food webs.



Computer-aided applications in pharmaceutical technologyEdited by J Djuris, University of Belgrade, Serbia


Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology and chemometric methods with emphasis on their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology.

CONTENTSQuality by design in pharmaceutical development; Computer-aided formulation development; Experimental design application and interpretation in pharmaceutical technology; Chemometric methods application in pharmaceutical process analysis and control; Neural computing in pharmaceutical products and process development; Computer aided biopharmaceutical characterization; Computational fluid dynamics in pharmaceutical technology.



Open source software in life science researchPractical solutions to common challenges in the pharmaceutical industry and beyondEdited by L Harland, Pfizer and M Forster, Syngenta, UK


The free/open source approach has grown from a minor activity to become a significant producer of robust, task-orientated software for a wide variety situations and applications. Examples range from core infrastructure platforms such as the apache web-server, powerful document indexing and search tools such as Lucene, through to major user-orientated systems such as Mediawiki (which powers Wikipedia) and Drupal (which powers many diverse websites). To life science informatics groups, these systems present an appealing proposition - high quality software at a very attractive price. Open source software in life science research considers how industry and applied research groups have embraced these resources, discussing practical implementations that address real-world business problems.

CONTENTSPart 1 Laboratory data management and chemical informatics: Building research data handling systems with open source tools; Interactive predictive toxicology with Bioclipse and OpenTox; Utilizing open source software to facilitate communication of chemistry at RSC; Open source software for mass spectrometry and metabolomics; Open source software for image processing and analysis: Picture this with ImageJ; Integrated data analysis with KNIME; Investigation-Study-Assay, a toolkit for standardising data capture and sharing. Part 2 Genomics and bioinformatics tools: GenomicTools: An open-source platform for developing high-throughput analytics in genomics: Creating an in-house ‘omics’ data portal using EBI Atlas software; Setting up an ‘omics’ platform in a small biotech; Squeezing big data into a small organisation. Part 3 information and knowledge management: Design Tracker: An easy to use and flexible hypothesis tracking system to aid project team working; Free and open source software for web based collaboration; Developing scientific business applications using open source search and visualisation technologies; Utopia Documents: transforming how industrial scientists interact with the scientific literature. Part 4 Semantic technologies: Semantic MediaWiki in applied life science and industry: Building an enterprise encyclopaedia; Building disease and target knowledge with Semantic MediaWiki; Chem2Bio2RDF: a semantic resource for systems chemical biology and drug discovery; TripleMap: A web-based semantic knowledge discovery and collaboration application for biomedical research; Part 5 Clinical settings: Extreme scale clinical analytics with open source software; Validation and regulatory compliance of free/open source software. Part 6 Perspective: The economics of free/open source software in industry.



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Protein folding in silicoProtein folding versus protein structure predictionEdited by I Roterman-Konieczna, Jagiellonian University Medical College


Protein folding is a process by which a protein structure assumes its functional shape of conformation, and has been the subject of research since the publication of the first software tool for protein structure prediction. Protein folding in silico approaches this issue by introducing an ab initio model that attempts to simulate as far as possible the folding process as it takes place in vivo, and attempts to construct a mechanistic model on the basis of the predictions made. The opening chapters discuss the early stage intermediate and late stage intermediate models, followed by a discussion of structural information that affects the interpretation of the folding process. The second half of the book covers a variety of topics including ligand binding site recognition, the ‘fuzzy oil drop’ model and its use in simulation of the polypeptide chain, and misfolded proteins. The book ends with an overview of a number of other ab initio methods for protein structure predictions and some concluding remarks.

CONTENTSEarly Stage intermediate; Late stage intermediate; Structural information involved in the interpretation of the stepwise protein folding process; Divergence entropy characterizing the internal force field in proteins: Ligand binding site recognition; The “fuzzy oil drop” model to identify the complexation area in protein homodimers; Simulation of the polypeptide chain folding process using “fuzzy oil drop” model; Misfolded proteins; Short description of other selected ab initio methods for protein structure prediction.



Annotating new genesFrom in silico screening to experimental validationS Uchida, Max-Planck-Institute, Germany


In Annotating new genes the author considers his team’s approach as applied to evolutionary-conserved, heart-enriched genes with unknown functions. All the above mentioned methods have been validated by students working in the field of bioinformatics and developmental biology to provide a step-by-step methodology to obtain highly publishable data as well as knowledge creation that will aid the development of products which can be used in the field of regenerative medicine.

CONTENTSDatabases and software to make your research life easier; How to program like a bioinformatician? Case study: C-It, knowledge database for screening evolutionarily conserved, tissue-enriched, uncharacterized genes; Experimental validation: concepts and practice; Further application: adult stem cells and tissue regenerations; Conclusion.



MATLAB® in bioscience and biotechnologyL Burstein, Technion, Haifa University, Israel


MATLAB® in bioscience and biotechnology presents an introductory Matlab course oriented towards various collaborative areas of biotechnology and bioscience. It concentrates on Matlab fundamentals and gives examples of its application to a wide range of current bioengineering problems in computational biology, molecular biology, bio-kinetics, biomedicine, bioinformatics, and biotechnology. In this book, Matlab is presented with examples and applications to various school-level and advanced bioengineering problems - from growing populations of microorganisms and population dynamics, reaction kinetics and reagent concentrations, predator-prey models, mass-transfer and flow problems, to sequence analysis and sequence statistics.

CONTENTSMATLAB® basics; MATLAB® graphics; Script, function files and some useful MATLAB® functions; Ordinary and partial differential equation solvers; Bioinformatics tool for sequence analysis.



GENETICS AND GENOMICS

Gene expression analysis in the RNA worldJ Q Clement, Texas Southern University, USA


Gene expression analysis in the RNA world is a practical guide to the principles and techniques that are essential to RNA-based gene expression analysis. Key features include a detailed presentation of the procedures and methods for triplicates, time course, and recovery studies involving the use of multiple microarrays and correlation analysis between microarray results, RT-PCR, and Northern blotting. Each step of the microarray experimental process from bench work of RNA isolation through to computational and bioinformatics analysis is described in detail.

CONTENTSGene expression regulation - the concept and practice of a Rnase-Free Lab; Total RNA isolation through ultracentrifugation versus commercial kits, RNA integrity assessment; Using total RNA for gene-specific expression studies using RT-PCR and Northern Analysis; Using total RNA for genome-wide expression studies using microarray analysis; Critical comments on bioinformatics software and web-based resources.



Computational methods for finding inferential bases in molecular geneticsQ-N Tran, Lamar (Texas State) University, USA


Computational methods for finding inferential bases in molecular genetics covers computational methods for selecting relevant biomolecules such as genes and protein kinases with an emphasis on a new method.

CONTENTSPart 1 Introduction: Introduction. Part 2 Computational methods for gene selection: Preliminaries for gene selection and classification methods; Gene selection using Gini ratios and Loren curves; Experimentation. Part 3 Computational methods for quantitative analysis of kinase inhibitor selectivity. Preliminaries for kinase inhibitors and their selectivity; Kinase selection for selectivity analysis; Experimentation. Part 4 Software development: Implementation; Practical usage of the software.



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Annotating new genesFrom in silico screening to experimental validationS Uchida, Max-Planck-Institute, Germany


In Annotating new genes the author considers his team’s approach as applied to evolutionary-conserved, heart-enriched genes with unknown functions. All the above mentioned methods have been validated by students working in the field of bioinformatics and developmental biology to provide a step-by-step methodology to obtain highly publishable data as well as knowledge creation that will aid the development of products which can be used in the field of regenerative medicine.

CONTENTSDatabases and software to make your research life easier; How to program like a bioinformatician? Case study: C-It, knowledge database for screening evolutionarily conserved, tissue-enriched, uncharacterized genes; Experimental validation: concepts and practice; Further application: adult stem cells and tissue regenerations; Conclusion.



Concepts and techniques in genomics and proteomicsN Saraswathy and P Ramalingam, Kumaraguru College of Technology, India


Concepts and techniques in genomics and proteomics covers the important concepts of high-throughput modern techniques used in the genomics and proteomics field. Each technique is explained with its underlying concepts, and simple line diagrams and flow charts are included to aid understanding and memory. A summary of key points precedes each chapter within the book, followed by detailed description in the subsections. Each subsection concludes with suggested relevant original references.

CONTENTSIntroduction to genes and genomes; The human genome project; Genomes of model organisms; High capacity vectors; DNA sequencing methods; Genome mapping; Genome sequencing methods; Genome sequence assembly and annotation; Functional genomics; Introduction to proteomics; Two-dimensional gel electrophoresis of proteins; Mass spectrometry for proteomics; Protein Identification by Peptide Mass Fingerprinting (PMF); Protein sequencing techniques; Phosphoproteomics; Glycoproteomics.



INTELLECTUAL PROPERTY, REGULATION

The impact of regulation on drug developmentG H Hennings, hgh regulatory sciences, Germany


The impact of regulation on drug development provides the reader with a basic understanding of the evolution of global regulatory standards relevant to the research and development process of medicinal products and the role regulatory science plays. This book provides practical guidance on how to obtain such advice efficiently and how it is incorporated in global regulatory planning and strategies.

CONTENTSDeveloping effective medicines - a contribution to public health; Evolution and maintenance of global regulatory standards; Current regulatory issues of research and development pipelines; The value chain from discovery to post-authorisation research; Health authorities provide scientific (and regulatory) advice; Strategic regulatory plans and planning.



Patent litigation in the pharmaceutical and biotechnology industriesG E Morgan, Winston & Strawn LLP, UK


Patent litigation in the pharmaceutical and biotechnology industries focuses on the key subject of multi-jurisdictional patent litigation strategies and product lifecycle management in the pharmaceutical and biotechnology industries. This book therefore looks at the characteristics and strategies typically employed in fighting multi-jurisdictional litigation within these industries. In particular, patentability and the enforceability of biotechnological inventions are examined as they remain one of the most fluid, commercially important and emotive topics in the patent industry.

CONTENTSChoosing your forum; Litigating in the US; Litigating in Europe; Litigating pharma patents; Litigating biotechnology patents; The US ITC regime; Medicinal regulatory considerations; Patent term extension and the SPC regime; A unified patent litigation system for Europe; Conclusions.



Patently innovativeHow pharmaceutical firms use emerging patent law to extend monopolies on blockbuster drugsR A Bouchard, Intellectual Property Lawyer and Scholar, Canada


Patently innovative provides a review of the importance of traditional patent law and emerging linkage regulations for pharmaceutical products on the global stage, with a focus on the linkage regime in Canada. The primary focus is on how innovation in the pharmaceutical sector can be strongly regulated and how government regulation can either stimulate or inhibit development of breakthrough products.

CONTENTSDrug approval, drug patenting, pharmaceutical linkage, and public health policy; Empirical analysis of drug approval; Empirical analysis of pharmaceutical innovation and drug approval-drug patenting linkage; Empirical analysis of drug patenting in multiple high-value cohorts; Implications of empirical data: Are pharmaceutical linkage regulations a success? Future directions: Testable hypotheses and evolution toward global pharmaceutical linkage.



Contract research and manufacturing services (CRAMS) in IndiaThe business, legal, regulatory and tax environment in the pharmaceutical and biotechnology sectorsM Antani and G Gokhale, Nishith Desai Associates, India


Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations.

CONTENTSOverview of CRAMS; Legal and regulatory scenario; Issues and concerns; Tax environment and related issues; Service agreements; Negotiating a contract; Outlook and conclusion.



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LIFE SCIENCE, MOLECULAR AND CELLULAR BIOLOGY

Fed-batch fermentationA practical guide to scalable recombinant protein production in Escherichia coliG G Moulton and T Vedvick, Infectious Disease Research Institute (IDRI), USA


Fed-batch fermentation is primarily a practical guide for recombinant protein production in E. coli using a fed-batch fermentation process. Ideal users of this guide are teaching labs and R&D labs that need a quick and reproducible process for recombinant protein production. It may also be used as a template for the production of recombinant protein product for use in clinical trials. The guide highlights a method whereby a medium cell density - final Ods = 30-40 (A600) - fed-batch fermentation process can be accomplished within a single day with minimal supervision. This process can also be done on a small (2L) scale that is scalable to 30L or more. All reagents (media, carbon source, plasmid vector and host cell) used are widely available and are relatively inexpensive. This method has been used to produce three different protein products following cGMP guidelines for Phase I clinical studies.

CONTENTSIntroduction to fermentation; Typical recombinant E. coli host cells and plasmids used; Generation of recombinant clone and working cell bank; Generation of inoculants for fed-batch culture; Fed-batch culture method; Analysis of growth and production data; Parametric analysis for periplasmic soluble production of recombinant product.



Ultrafiltration for bioprocessingH Lutz, Millipore Corporation, USA


Ultrafiltration (UF) is a key process in the bioprocessing area and is used in almost every bioprocess. Ultrafiltration for bioprocessing is written by a leading worker in the area and includes many practical applications and case studies. It is key reading for all those involved in the biotechnology and biopharmaceutical areas.

CONTENTSFundamentals; Membranes; Modules; Process configurations; Processing; Recovery; Cleanup; Manufacturing systems; Trouble shooting.



Marine enzymes for biocatalysisSources, biocatalytic characteristics and bioprocesses of marine enzymesA Trincone, Istituto di Chimica Biomolecolare (I.C.B.), Italy


Marine enzymes for biocatalysis initially examines the nature and level of interest in marine biological diversity, and outlines the fundamentals of biocatalysis. It goes on to detail sources of marine enzymes, and to analyse examples from both chemical and stereochemical viewpoints of catalysis, including microbial enzymes and animal or plant sources. The book goes on to explore the future potential of marine bioprospecting in biocatalysis.

CONTENTSSource of marine enzymes; Processes and biocatalytic characteristics; Bioprocesses; Biocatalytic characteristics.



Gene expression analysis in the RNA worldJ Q Clement, Texas Southern University, USA


Gene expression analysis in the RNA world is a practical guide to the principles and techniques that are essential to RNA-based gene expression analysis. Key features include a detailed presentation of the procedures and methods for triplicates, time course, and recovery studies involving the use of multiple microarrays and correlation analysis between microarray results, RT-PCR, and Northern blotting. Each step of the microarray experimental process from bench work of RNA isolation through to computational and bioinformatics analysis is described in detail.

CONTENTSGene expression regulation - the concept and practice of a Rnase-Free Lab; Total RNA isolation through ultracentrifugation versus commercial kits, RNA integrity assessment; Using total RNA for gene-specific expression studies using RT-PCR and Northern Analysis; Using total RNA for genome-wide expression studies using microarray analysis; Critical comments on bioinformatics software and web-based resources.



RNA interferenceTherapeutic developmentsT Novobrantseva, Meena, P Ge and G Hinkle, Alnylam Pharmaceuticals, USA


RNA interference, written by leading researchers in the field, covers selection of siRNA, screening for the active molecules, general considerations in introducing chemical modifications, as well as discussing formulations used to deliver siRNA and applications of RNAi in many exciting therapeutic areas.

CONTENTSBiology and history of RNAi; Ways of introducing RNAi into mammalian cells; Designing potent and specific synthetic siRNA; Chemistry of siRNA molecules; Issue of delivery; Delivery methods; Clinical application of siRNA.



An introduction to biotechnologyThe science, technology and medical applicationsW T Godbey, Tulane University, USA


An introduction to biotechnology is a biotechnology textbook aimed at undergraduates. It covers the basics of cell biology, biochemistry and molecular biology, and introduces laboratory techniques specific to the technologies addressed in the book; it addresses specific biotechnologies at both the theoretical and applications levels.

CONTENTSPart 1 The cell: Plasma membrane - phospholipids, proteins, cholesterol: Prokaryotic outer barriers - cell wall (NAMs, NAGs, crosslinking); The cytoplasm - more proteins: Enzymes (enzymes are catalysts, enzymes depend on proper protein folding, enzymes used in science, enzymes used in industry; The nucleus - organization of the genome (chromosomes, DNA fibers, nucleosomes, DNA strands, RNA); Prokaryotic genome organization - circular genome, attached to inner plasma membrane; The central dogma - transcription (mRNA); The life of a cell - the cell cycle (synthesis (S) phase, mitosis (M), gap phases, cell cycle control). Part 2 Biotechnology: Applications to and of the cell; Genetic engineering - genes (exons, introns, promoters, enhancers); Gene delivery models - viral (adenovirus, adeno-associated virus, herpesvirus, lentivirus/retrovirus); Gene delivery cargo - DNA, RNA, siRNA; Fluorescence - quantum yield, Stokes’ shift, brightness; Recombinant Proteins; Biofuels - from cellulose degradation (biochemistry of cellulose); Stem cells - cells with potential (totipotent, pluripotent, multipotent); Transgenics; Cloning.



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From plant genomics to plant biotechnologyP Poltronieri, Italian National Research Council, Italy, N Burbulis, Aleksandr Stulginskis University, Lithuania and C Fogher, Catholic University, Italy


From plant genomics to plant biotechnology reviews the recent advancements in the post-genomic era, discussing how different varieties respond to abiotic and biotic stresses, understanding the epigenetic control and epigenetic memory (RNAs, DNA methylation, histone modifications and polycomb complexes), the roles of non-coding RNAs, applicative uses of RNA silencing and RNA interference in plant physiology and in experimental transgenics and plants modified to specific aims (biofuels, production of high-value pharmaceutical proteins in plants, abiotic stress resistant wood trees and ornamental plants). In the forthcoming years these advancements will support the production of plant varieties better suited to resist biotic and abiotic stresses, for food and non-food applications.

CONTENTSIntroduction and overview on EU plant research networks; Approaches to plant microRNAs - identification of microRNAs and their targets using bioinformatic tools; Approaches to understanding the epigenetic control of chromatin states by the polycomb complexes; Approaches to SuperSAGE and Tag-DNA microarrays to chickpea studies - differential responses during salt stress in susceptible and resistant varieties; GrainLegumes Project - improvements of legume varieties and their exploitation; Application of doubled haploid technology in breeding of Brassica napus; Phenotyping platforms and field phenotyping equations for phenomics analysis and breeding progress; Approaches to functional genomics from strawberry and potato genome sequences; Approaches to pine tree functional genomics from the pine tree genome sequencing; Approaches in peach transcriptomics, tissue specific differential expression and peach phenotyping; Approaches in grapevine genomics to understand the environmental responses in grape varieties and improve disease resistance; Approaches to plant research and plant biotechnology for pharma and biofuel sectors; Conclusions – outlook.



Bacterial cellular metabolic systemsMetabolic regulation of a cell system with 13C-metabolic flux analysisK Shimizu, Kyushu Institute of Technology and Institute of Advanced Biosciences of Keio University, Japan


Bacterial cellular metabolic systems focuses on this highly topical subject in relation to culture environment and provides a detailed analysis from gene level to metabolic level regulation, as well as offering a discussion of the most recent modelling approaches. The book begins with an introduction to metabolic mechanisms and to the metabolic regulation of a cell, before moving onto discuss the action of global regulators in response to a specific culture environment. The second half of the book examines conventional flux balance analysis and its applications, 13C-metabolic flux analysis, and the effect of a specific gene knockout on the metabolism.

CONTENTSMain metabolism; Brief overview of metabolic regulation of a bacterial cell; Metabolic regulation by global regulators in response to culture environment; Conventional flux balance analysis and its applications; 13C-metabolic flux analysis and its applications; Effect of a specific-gene knockout on the metabolism.



Therapeutic protein drug productsPractical approaches to formulation in the laboratory, manufacturing, and the clinicEdited by B K Meyer, Merck Research Laboratories (MRL), USA


Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic.

CONTENTSCommercial therapeutic protein drug products; A formulation method to improve the physical stability of macromolecular-based drug products; Properties of protein formulations; Material and process compatibility testing; Compounding and filling: Drug substance to drug product; Administration in the clinic; Regulatory guidelines for the development of a biotechnology drug product.



Human papillomavirus infectionsFrom the laboratory to clinical practiceF Cobo, Hospital de Poniente, Spain


Human papillomavirus (HPV) is one of the most common causes of sexually transmitted diseases worldwide, both in men and women. Human papillomavirus infections provides the scientific background needed to understand the natural history and pathogenesis of HPV infection and offers discussion of its clinical features, diagnosis, treatment and prevention. The book begins with chapters covering the epidemiology, virology, history and transmission of the infection, as well as its pathogenesis and clinical features. Following a discussion of the relationship between HPV and cancer, chapters in the second half of the book look at diagnosis, testing and treatment. The book concludes with detailed coverage of the prevention of HPV through worldwide vaccination programmes.

CONTENTSIntroduction and epidemiological data; Basic virology: Structure and nomenclature; Natural history and transmission: Anatomic distribution; Pathogenesis and clinical features; HPV infection and association with cancer; Diagnosis of HPV infection; Clinical utility of HPV testing; Treatment; Prevention: HPV vaccines.



Concepts and techniques in genomics and proteomicsN Saraswathy and P Ramalingam, Kumaraguru College of Technology, India


Concepts and techniques in genomics and proteomics covers the important concepts of high-throughput modern techniques used in the genomics and proteomics field. Each technique is explained with its underlying concepts, and simple line diagrams and flow charts are included to aid understanding and memory. A summary of key points precedes each chapter within the book, followed by detailed description in the subsections. Each subsection concludes with suggested relevant original references.

CONTENTSIntroduction to genes and genomes; The human genome project; Genomes of model organisms; High capacity vectors; DNA sequencing methods; Genome mapping; Genome sequencing methods; Genome sequence assembly and annotation; Functional genomics; Introduction to proteomics; Two-dimensional gel electrophoresis of proteins; Mass spectrometry for proteomics; Protein Identifi cation by Peptide Mass Fingerprinting (PMF); Protein sequencing techniques; Phosphoproteomics; Glycoproteomics.



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Therapeutic antibody engineeringCurrent and future advances driving the strongest growth area in the pharma industryW R Strohl, Johnson & Johnson Biotechnology Center of Excellence and L M Strohl, Medical Illustrator, USA


Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on candidates of the future. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. In the following chapters, the book covers a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering.

CONTENTSIntroduction to biologics and monoclonal antibodies; Value proposition for therapeutic monoclonal antibodies and Fc fusion proteins; Antibody structure–function relationships; Fundamental technologies for antibody engineering; Sources of antibody variable chains; Variable chain engineering – humanization and optimization approaches; Antibody interactions with the immune system; Monoclonal antibody targets and mechanisms of action; Therapeutic antibody classes; Antibody Fc engineering for optimal antibody performance; IgG glycans and glyco-engineering; Antibody fragments as therapeutics; Multiple antibody and multi-specificity approaches; Fc fusion proteins and similar constructs using Fc; Antibody-drug conjugates; Development issues: Antibody stability, developability, immunogenicity, and comparability; Interactions of human IgGs with non-human systems; Cell line development; Issues facing therapeutic monoclonal antibodies for the future.



Open source software in life science researchPractical solutions to common challenges in the pharmaceutical industry and beyondEdited by L Harland, Pfizer and M Forster, Syngenta, UK


The free/open source approach has grown from a minor activity to become a significant producer of robust, task-orientated software for a wide variety situations and applications. Examples range from core infrastructure platforms such as the apache web-server, powerful document indexing and search tools such as Lucene, through to major user-orientated systems such as Mediawiki (which powers Wikipedia) and Drupal (which powers many diverse websites). To life science informatics groups, these systems present an appealing proposition - high quality software at a very attractive price. Open source software in life science research considers how industry and applied research groups have embraced these resources, discussing practical implementations that address real-world business problems.

CONTENTSPart 1 Laboratory data management and chemical informatics: Building research data handling systems with open source tools; Interactive predictive toxicology with Bioclipse and OpenTox; Utilizing open source software to facilitate communication of chemistry at RSC; Open source software for mass spectrometry and metabolomics; Open source software for image processing and analysis: Picture this with ImageJ; Integrated data analysis with KNIME; Investigation-Study-Assay, a toolkit for standardising data capture and sharing. Part 2 Genomics and bioinformatics tools: GenomicTools: An open-source platform for developing high-throughput analytics in genomics: Creating an in-house ‘omics’ data portal using EBI Atlas software; Setting up an ‘omics’ platform in a small biotech; Squeezing big data into a small organisation. Part 3 information and knowledge management: Design Tracker: An easy to use and flexible hypothesis tracking system to aid project team working; Free and open source software for web based collaboration; Developing scientific business applications using open source search and visualisation technologies; Utopia Documents: transforming how industrial scientists interact with the scientific literature. Part 4 Semantic technologies: Semantic MediaWiki in applied life science and industry: Building an enterprise encyclopaedia; Building disease and target knowledge with Semantic MediaWiki; Chem2Bio2RDF: a semantic resource for systems chemical biology and drug discovery; TripleMap: A web-based semantic knowledge discovery and collaboration application for biomedical research; Part 5 Clinical settings: Extreme scale clinical analytics with open source software; Validation and regulatory compliance of free/open source software. Part 6 Perspective: The economics of free/open source software in industry.



MANAGEMENT AND BUSINESS

The impact of regulation on drug developmentG H Hennings, hgh regulatory sciences, Germany


The impact of regulation on drug development provides the reader with a basic understanding of the evolution of global regulatory standards relevant to the research and development process of medicinal products and the role regulatory science plays, i.e. the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of regulated products. This book provides practical guidance on how to obtain such advice efficiently and how it is incorporated in global regulatory planning and strategies.

CONTENTSDeveloping effective medicines - a contribution to public health; Evolution and maintenance of global regulatory standards; Current regulatory issues of research and development pipelines; The value chain from discovery to post-authorisation research; Health authorities provide scientific (and regulatory) advice; Strategic regulatory plans and planning.



The funding of biopharmaceutical research and developmentD R Williams, Appalachian State University, USA


The funding of biopharmaceutical research and development provides a comprehensive critical review of the funding of research and development (R&D) in the human biopharmaceutical market sector. It addresses both private and public funding sources available in the US and internationally.

CONTENTSPurpose, cost and risk of bringing a drug to market; Structure of the book; An introduction to the biopharmaceutical market; Synopsis of theories of the firm and valuation methods; Innovation and the merging of the pharmaceutical and biotechnology industries; The funding of basic research and public-private partnerships; Public-private partnerships; Strategic alliances; Angel and venture capital; Initial Public Offering (IPO).



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Successful biopharmaceutical operationsDriving changeC Driscoll, Driscoll Consulting Group, USA


Successful biopharmaceutical operations provides a practical guide to transforming biopharma companies into industry leaders through a focus on driving change. The industry has a blind spot concerning this kind of work, because successful change management comes from a focus on people, while our technically-minded ranks invariably prefer a technical focus. This cognitive bias causes us to pick up the tools we like the best and to swing them enthusiastically - whether they are working or not. This book provides new tools, and readers gain an understanding of how biopharma organizations developed into the cultures we see currently.

CONTENTSPart 1 The need for change: Something isn’t right?; The problem of smart people; The ease of fundamentalism; The silo skyline; Integrating the appearance of improvement; Call it what it is: Cost reduction; When you turn the wheel and nothing happens; When you take public opinion polls to see what’s wrong; When you realize you run a daycare center. Part 2 The change process: Change management framework; Cognitive bias; The compliance card; Simplicity vs. complexity; Accountability vs. innocent bystander; Bringing it all together: Engagement, gameplan, sustainability. Part 3 Noise (you’ll want to read this): Lessons from Oobleck; They’re under too much pressure; we need to give them time; they don’t feel comfortable bringing things up.



Patent litigation in the pharmaceutical and biotechnology industriesG E Morgan, Winston & Strawn LLP, UK


Patent litigation in the pharmaceutical and biotechnology industries focuses on the key subject of multi-jurisdictional patent litigation strategies and product lifecycle management in the pharmaceutical and biotechnology industries. This book therefore looks at the characteristics and strategies typically employed in fighting multi-jurisdictional litigation within these industries.

CONTENTSChoosing your forum; Litigating in the US; Litigating in Europe; Litigating pharma patents; Litigating biotechnology patents; The US ITC regime; Medicinal regulatory considerations; Patent term extension and the SPC regime; A unified patent litigation system for Europe; Conclusions.



21st Century quality management and good management practicesValue added compliance for the pharmaceutical and biotechnology industryS Williams, Consultant, Australia


21st Century quality management and good management practices is a practical guide on how to apply these 21st century principles in the pharmaceutical and biotechnology workplace and include simple understandable examples and case studies on modern compliance.

CONTENTSInternational rules and regulations in the life science industry; Pharmaceutical quality management and quality systems (ICH Q10); Fundamentals of good manufacturing practices (GMP); Validation; Pharmaceutical quality risk management (ICH Q9); Building quality into products (ICH Q8 and QbD); Process control and process analytical technology; CAPA, failure investigation and root cause analysis; Effective training and education; Behavioural GMPs, deviations and human error reduction; Supply chain integrity; Compliance auditing and product reviews.



Lean biomanufacturingN J Smart, Smart Consulting Group, USA


The objective of this book is to re-visit lean principles and then apply them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes.

CONTENTSLean techniques/methods to be applied to biomanufacturing; Creation and execution of an implementation plan; Issues and problems for the pharmaceutical industry that make the situation challenging; Developing a lean approach for biopharmaceutical processes; The contribution of simulation models in the development of lean biopharmaceutical processes: Review of case studies; Integration of biomanufacturing with lean laboratory operations; The seven lean compliance considerations connected with enabling lean biomanufacturing; Ready to use technologies and their role in lean biomanufacturing.



The application of statistical process control in the pharmaceutical and biotechnology industriesA practical approachT Cochrane, Napp Pharmaceutical Group, UK


The application of statistical process control in the pharmaceutical and biotechnology industries is a starting point for anyone interested in or who has been tasked with introducing these new pharma initiatives. It is a practical guide on how to apply statistical process control or SPC within the pharmaceutical industry. The book considers the various areas where SPC thinking can be applied and demonstrates the benefits that can be achieved by its use.

CONTENTSHistory of statistical process control; Why now in the pharmaceutical and biotech industry; Getting the culture right; The pharmaceutical industry; The system; SPC theory; Raw materials and supplier development; Key parameters; Auditing; Manufacturing processes; Training; Finished product testing; Critical quality attributes; Validation; Continuous verification; The annual product review; Putting all the information together; Reducing the risk in the system; Continuous improvement teams; Sales; Case studies.



Orphan drugsUnderstanding the rare disease market and its dynamicsE Hernberg-Stahl, Late Phase Solutions Europe AB, Sweden


This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe. Before the orphan drug legislation enacted in the US in 1983, there was a limited interest from industry to develop treatment for very small patient groups.

CONTENTSWhat is an orphan drug? Orphan drug legislation; Patient network and advocacy groups; Organizations and networks dedicated and contributing to the dissemination of knowledge about rare diseases and orphan drugs; US Congress/ EU Commission initiated collaborative activities; Designing robust clinical trials for orphan drugs.



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CAPA in the pharmaceutical and biotech industriesHow to implement an effective nine step programJ Rodriguez, Monarch Quality Systems Solutions, USA


CAPA in the pharmaceutical and biotech industries contains the most current information on how to implement, develop and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a 9-step closed-loop process approach for medical device, pharmaceutical and biologic manufacturers, as well as any company or institution, which has to maintain a quality system.

CONTENTSStep-by-step basics on how to build a comprehensive CAPA program; how to use a 9-step CAPA process to effectively handle any product or quality system failures; How to effectively use failure investigations and CAPA in order to handle, and process complaints investigations in a timely manner; How to effectively use risk management concepts to assign a risk level to failure investigations in order to prioritize based on risk.; How to use Failure Mode and Effect Analysis to identify potential failure modes; How to review data from post production, and post market in order to determine the need for changes as well as new mitigations activities; Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions; Efficient used of root cause analysis tools; Optimizing CAPA and RCA documentation procedures; Essential SOPs and other documentation; Review areas of common FDA’s 483 inspection observations; How to effectively identify and track deviations and non-conformances; Learning to analyse and trend data to identify existing and potential causes of non-conformance; Gathering, organizing and managing the correct data required to conduct and effective Root Cause Investigation; Review the elements of a good investigation; Integrating RCA and CAPA with other systems such as: Internal auditing, deviations, Out Of Specification (OOS) and complaint handling; Performing trend analysis and using effective RCA tools; How to use of statistical methodologies when performing Root Cause Analysis; CAPA and the linkage to effective management review and annual product reviews; Step-by-step basics on how to build your own comprehensive CAPA program; Most important: Review of the real benefits of an effective CAPA system.



Therapeutic risk management of medicinesA K Banerjee and S Mayall, Pope Woodhead & Associates, UK


Therapeutic risk management of medicines is an authoritative, and yet practical guide on planning, writing, implementing and evaluating risk management plans for medicines globally. Chapters are also included on the historical development, lessons from other industries, the regulatory and health authority perspective and public communication of benefit risk. This topic is of critical importance not only to the pharmaceutical and biotechnology industry, but also prescribers, pharmacists, regulators and healthcare policymakers.

CONTENTSIntroduction and historical background of risk management plans; EU-RMP (Risk Management Plan); USA REMS (Risk Evaluation and Mitigation Strategies); Safety specification; Pharmacovigilance planning; Assessing the need for risk minimization; Risk minimization tools; Implementation of RMPs and REMS; Evaluation of RMPs and REMS; Developmental risk management plans; Effectively negotiating with the health authorities; Public communication of benefit risk.



Patently innovativeHow pharmaceutical firms use emerging patent law to extend monopolies on blockbuster drugsR A Bouchard, Intellectual Property Lawyer and Scholar, Canada


Patently innovative provides a review of the importance of traditional patent law and emerging linkage regulations for pharmaceutical products on the global stage, with a focus on the linkage regime in Canada. The primary focus is on how innovation in the pharmaceutical sector can be strongly regulated and how government regulation can either stimulate or inhibit development of breakthrough products.

CONTENTSDrug approval, drug patenting, pharmaceutical linkage, and public health policy; Empirical analysis of drug approval; Empirical analysis of pharmaceutical innovation and drug approval-drug patenting linkage; Empirical analysis of drug patenting in multiple high-value cohorts; Implications of empirical data: Are pharmaceutical linkage regulations a success? Future directions: Testable hypotheses and evolution toward global pharmaceutical linkage.



Contract research and manufacturing services (CRAMS) in IndiaThe business, legal, regulatory and tax environment in the pharmaceutical and biotechnology sectorsM Antani and G Gokhale, Nishith Desai Associates, India


Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks.

CONTENTSOverview of CRAMS; Legal and regulatory scenario; Issues and concerns; Tax environment and related issues; Service agreements; Negotiating a contract; Outlook and conclusion.



Clinical research in AsiaOpportunities and challengesU Sahoo, Chiltern, India


Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects.

CONTENTSClinical research in Asia; Clinical research in Japan; Clinical research in China; Clinical research in India; Clinical research in Taiwan; Clinical research in South Korea; Clinical research in Singapore; Clinical research in Thailand; Clinical research in Philippines; Clinical research in Malaysia; Clinical research in Vietnam.



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A biotech manager’s handbookA practical guideEdited by M O’Neill, Eolas Biosciences Limited and M M Hopkins, University of Sussex, UK


A biotech manager’s handbook lays out - in a simple straightforward manner - for the manager or would-be entrepreneur, the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts with outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur.

CONTENTSThe bioscience sector: Challenges and opportunities; Academic innovation: So you want to be a bio-entrepreneur? Leadership and you; Managing self, situations and stress; It’s all in the plan; Exploring funding routes for therapeutics firms; Raising funds and managing finances; Introduction to intellectual property; Managing projects and portfolios in R&D: Why and how; Successful registration of new therapies; Clinical trials: Design and practice; Business development: Starting out; Business development: To the deal and beyond; Conclusions and final thoughts.



Commercializing the stem cell sciencesO Harvey, University of Sydney, Australia


Commercializing the stem cell sciences offers a comparative analysis of the commercial methods adopted in the global stem cell industries, and seeks to establish whether there is an optimum commercial model, and to examine what emerging companies can learn from their predecessors. Following an introduction to stem cell sciences and the problems involved in their commercialization, the book begins with a discussion of stem cell treatments from a global perspective, and the role of innovation in the commercialization of biotechnology in general. In the second half of the book, chapters focus on the different strategies that can be employed and their relative risks and values, before a conclusion that looks at potential new developments in the field.

CONTENTSIntroduction: Stem cell science, biotechnology and the problem of commercialization; Stem cell treatments in a global marketplace; The role of innovation systems in the commercialization of biotechnology; Low-risk, low value strategies: Adult stem cells; High-risk, high-value: embryonic stem cells; Low-risk, low-value: iPS cells; Conclusion: What will happen next?



Outsourcing biopharma R&D to IndiaP R Chowdhury, J. Sagar Associates, India


Several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India.

CONTENTSBiopharma outsourcing in India: Its evolution; India’s core competitive advantage in R&D in the biopharma sector: The impetus for outsourcing; Different modes of outsourcing biopharma R&D to India; The Indian regulatory environment: A historical perspective; Implications of the changing regulatory environment in India; Creating contracts for outsourcing in the biopharma industry; Environmental, health and safety guidelines and biopharma outsourcing: An Indian perspective; Certifications; The need for due diligence of service providers.



Practical leadership for biopharmaceutical executivesJ Y Chin, Medical Science Liaison (MSL) Institute, USA


The biohealthcare executive in upper-middle management confronts leadership challenges unique to their industry: they manage highly specialized knowledge workers and innovators, compete at the speed of technology, work in a highly regulated environment where “free speech” often does not apply due to patient safety and privacy concerns, and increasingly are leading virtual teams who may be located in different parts of the world. Practical leadership for biopharmaceutical executives is a guide that strips away the theory and meets head-on the practical leadership challenges these executives face on a daily basis, and provides these “innovator leaders” with the tools to lead effectively in the face of technological complexity.

CONTENTSLeadership as a phenomenon; Seven managerial leadership competencies; Three commitments of pharmaceutical executives: presence; Three commitments of pharmaceutical executives: stewardship; Three commitments of pharmaceutical executives: development; Self-concept as leader; Conclusion: a new model of biopharmaceutical executive leadership.



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MANUFACTURING AND PROCESSING

Ultrafiltration for bioprocessingH Lutz, Millipore Corporation, USA


Ultrafiltration (UF) is a key process in the bioprocessing area and is used in almost every bioprocess. Ultrafiltration for bioprocessing is written by a leading worker in the area and includes many practical applications and case studies. It is key reading for all those involved in the biotechnology and biopharmaceutical areas.

CONTENTSFundamentals; Membranes; Modules; Process configurations; Processing; Recovery; Cleanup; Manufacturing systems; Trouble shooting.



21st Century quality management and good management practicesValue added compliance for the pharmaceutical and biotechnology industryS Williams, Consultant, Australia


21st Century quality management and good management practices is a practical guide on how to apply these 21st century principles in the pharmaceutical and biotechnology workplace and include simple understandable examples and case studies on modern compliance. The book serves as a practitioner’s guide and is an ideal companion for pharmaceutical and biotechnology industry professionals and students studying quality management and GMP compliance.

CONTENTSInternational rules and regulations in the life science industry; Pharmaceutical quality management and quality systems (ICH Q10); Fundamentals of good manufacturing practices (GMP); Validation; Pharmaceutical quality risk management (ICH Q9); Building quality into products (ICH Q8 and QbD); Process control and process analytical technology; CAPA, failure investigation and root cause analysis; Effective training and education; Behavioural GMPs, deviations and human error reduction; Supply chain integrity; Compliance auditing and product reviews.



Process validation for the production of biopharmaceuticalsPrinciples and best practiceA R Newcombe, Pfizer Biotechnology, Ireland and P Thillaivinayagalingam, Novartis Pharma S.A.S, France


Process validation for the production of biopharmaceuticals examines the practical, theoretical and regulatory aspects of process validation relevant to biopharmaceutical production and critically evaluates individual manufacturing unit operations. Chapters provide validation solutions applicable to a variety of commercial biopharmaceutical processes. The text includes a description of validation strategies and aspects of regulatory compliance with industry-focused practical examples. This book considers risk management strategies used for the selection of critical and key process parameters, along with the methodology used to categorise process outputs and define validation acceptance criteria.

CONTENTSThe Validation Master Plan (VMP); Process characterisation; Quality risk management; Buffer stability; Validation support studies; Cell culture (upstream); Drug product validation; Evaluating validation success post PV batch review and data analysis; Process analytics.



Lean biomanufacturingN J Smart, Smart Consulting Group, USA


The objective of this book is to re-visit lean principles and then apply them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes.

CONTENTSLean techniques/methods to be applied to biomanufacturing; Creation and execution of an implementation plan; Issues and problems for the pharmaceutical industry that make the situation challenging; Developing a lean approach for biopharmaceutical processes; The contribution of simulation models in the development of lean biopharmaceutical processes: Review of case studies; Integration of biomanufacturing with lean laboratory operations; The seven lean compliance considerations connected with enabling lean biomanufacturing; Ready to use technologies and their role in lean biomanufacturing.



The application of statistical process control in the pharmaceutical and biotechnology industriesA practical approachT Cochrane, Napp Pharmaceutical Group, UK


The application of statistical process control in the pharmaceutical and biotechnology industries is a starting point for anyone interested in or who has been tasked with introducing these new pharma initiatives. It is a practical guide on how to apply statistical process control or SPC within the pharmaceutical industry. The book considers the various areas where SPC thinking can be applied and demonstrates the benefits that can be achieved by its use.

CONTENTSHistory of statistical process control; Why now in the pharmaceutical and biotech industry; Getting the culture right; The pharmaceutical industry; The system; SPC theory; Raw materials and supplier development; Key parameters; Auditing; Manufacturing processes; Training; Finished product testing; Critical quality attributes; Validation; Continuous verification; The annual product review; Putting all the information together; Reducing the risk in the system; Continuous improvement teams; Sales; Case studies.



Stem cell bioprocessingFor cellular therapy, diagnostics and drug developmentT G Fernandes, M M Diogo and J M S Cabral, Instituto Superior Técnico (IST), Technical University of Lisbon, Portugal


Stem cell bioprocessing describes the main large-scale bioprocessing strategies for both stem cell culture and purification, envisaging the application of these cells for regenerative medicine and drug screening. Bioreactor configurations are described, including their applications for stem cell expansion and/or differentiation. Stem cell separation techniques are also discussed, aiming towards both isolation and purification of rare stem cell populations.

CONTENTSStem cells; Stem cell culture; Bioreactors for stem cell culture; Stem cell bioseparation; Micro-scale technologies for stem cell culture and separation; Stem cells and regenerative medicine.



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CAPA in the pharmaceutical and biotech industriesHow to implement an effective nine step programJ Rodriguez, Monarch Quality Systems Solutions, USA


CAPA in the pharmaceutical and biotech industries contains the most current information on how to implement, develop and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a 9-step closed-loop process approach for medical device, pharmaceutical and biologic manufacturers, as well as any company or institution, which has to maintain a quality system.

CONTENTSStep-by-step basics on how to build a comprehensive CAPA program; how to use a 9-step CAPA process to effectively handle any product or quality system failures; How to effectively use failure investigations and CAPA in order to handle, and process complaints investigations in a timely manner; How to effectively use risk management concepts to assign a risk level to failure investigations in order to prioritize based on risk.; How to use Failure Mode and Effect Analysis to identify potential failure modes; How to review data from post production, and post market in order to determine the need for changes as well as new mitigations activities; Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions; Efficient used of root cause analysis tools; Optimizing CAPA and RCA documentation procedures; Essential SOPs and other documentation; Review areas of common FDA’s 483 inspection observations; How to effectively identify and track deviations and non-conformances; Learning to analyse and trend data to identify existing and potential causes of non-conformance; Gathering, organizing and managing the correct data required to conduct and effective Root Cause Investigation; Review the elements of a good investigation; Integrating RCA and CAPA with other systems such as: Internal auditing, deviations, Out Of Specification (OOS) and complaint handling; Performing trend analysis and using effective RCA tools; How to use of statistical methodologies when performing Root Cause Analysis; CAPA and the linkage to effective management review and annual product reviews; Step-by-step basics on how to build your own comprehensive CAPA program; Most important: Review of the real benefits of an effective CAPA system.



MEDICAL SCIENCE AND TECHNOLOGY, CANCER RESEARCH

Medical education, training and care delivery in a virtual worldK Kahol, Arizona State University, USA


Medical education, training and care delivery in a virtual world provides a one-stop shop for educators, universities and researchers looking to employ virtual worlds for delivering medical education, training and employ virtual worlds for clinical purposes. The book provides theoretical basis and practical resources for virtual-environment-driven medical education and healthcare. It discusses virtual worlds and their basic characteristics, compares virtual social environments with conventional face-to-face interaction, provides guidance for setting up a virtual world, and discusses issues including the capabilities and suitability of commercial virtual worlds for medical education and healthcare applications, related research efforts, and ethical and financial considerations.

CONTENTSIntroduction to virtual worlds; Virtual worlds: Some examples; Techniques; Setting the virtual universe; Setting your avatars; Setting the interactions; Meetings in virtual worlds; Applications; Training for technical and cognitive skills in virtual worlds; Team training in virtual environments; Validating virtual world training; Delivery of clinical care through virtual worlds: Guidelines, challenges and opportunities; Ethical and financial issues of virtual worlds.

220 pages 234 x 156mm (6 x 9) hardback Q1 2014ISBN: 978 1 907568 03 9 E-ISBN: 978 1 908818 52 2Approx. £99.00/US$170.00/€120.00

paperback ISBN: 978 1 907568 02 2


Electroporation-based therapies for cancerFrom basics to clinical applicationsEdited by R Sundararajan, Purdue University, USA


Electroporation-based therapies for cancer provides a comprehensive overview of electroporation-based clinical studies in the hospitals for various cancer treatments including melanomas, head and neck cancers, chest wall breast carcinomas and colorectal cancers, and also looks at research studies in the lab using cell lines, primary cells, and animals.

CONTENTSClinical electro-chemo-therapy for advanced superficial melanoma; Effective electro-chemo-therapy for chest wall recurrence of breast carcinoma; Electrochemotherapy - aspects of clinical experience; Low and high voltage electro-chemo-therapy for breast cancer: An in vitro model study; Electrically-enhanced proliferation control of cancer-stem-cells-like adult human mesenchymal stem cells: A novel modality of treatment; Why electroporation is a useful technique for cancer treatments; Electro-endocrine therapy for breast cancer; Electroporation of cervical and leukemia cancer cells; Targeted delivery of siRNA and other difficult to transfect molecules using electroporation; Nanosecond, low voltage pulses for electro-endocrine therapy; Low and high voltage electroporation of ovarian cancer cells; Irreversible electroporation; Electric field distribution study of malignant tumors.



Bioinformatics for biomedical science and clinical applicationsK-H Liang, LinKo Medical Center, Chang Gung Memorial Hospital, Taiwan R.O.C.


Contemporary biomedical and clinical research are undergoing constant development thanks to the rapid advancement of various high throughput technologies at the DNA, RNA and protein levels. These technologies can generate vast amounts of raw data, making bioinformatics methodologies essential in their use for basic biomedical and clinical applications. Bioinformatics for biomedical science and clinical applications demonstrates what these cutting-edge technologies can do and examines how to design an appropriate study, including how to deal with data and address specific clinical questions.

CONTENTSGeneral introduction: From uncertainty to adaptivity; Transcriptomics; Systems biomedical science; Clinical developments; Concluding remarks.



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NMR metabolomics in cancer researchM Cuperlovic-Culf, National Research Council of Canada Institute for Information Technology, Canada


NMR metabolomics in cancer research presents a detailed account of the NMR spectroscopy methods applied to metabolomics mixture analysis along with a discussion of their advantages and disadvantages. Following an overview of the potential use of NMR metabolomics in cancer research, the book begins with an examination of the cancer metabolic phenotype and experimental methodology, before moving on to cover data pre-processing and data analysis. Chapters in the latter part of the book look at dynamic metabolic profiling, biomarker discovery, and the application of NMR metabolomics for different types of cancer, before a concluding chapter discusses future perspectives in the field.

CONTENTSBiology – Cancer metabolic phenotype; Experimental methodology; Metabolomics NMR data pre-processing – analysis of individual spectrum; Metabolomics data analysis – processing and analysis of a dataset; Dynamic metabolic profiling and metabolite network and pathways modelling; Biomarker discovery; NMR metabolomics application by cancer type; Perspectives.



Human papillomavirus infectionsFrom the laboratory to clinical practiceF Cobo, Hospital de Poniente, Spain


Human papillomavirus infections provides the scientific background needed to understand the natural history and pathogenesis of HPV infection and offers discussion of its clinical features, diagnosis, treatment and prevention. The book begins with chapters covering the epidemiology, virology, history and transmission of the infection, as well as its pathogenesis and clinical features. Following a discussion of the relationship between HPV and cancer, chapters in the second half of the book look at diagnosis, testing and treatment.

CONTENTSIntroduction and epidemiological data; Basic virology: Structure and nomenclature; Natural history and transmission: Anatomic distribution; Pathogenesis and clinical features; HPV infection and association with cancer; Diagnosis of HPV infection; Clinical utility of HPV testing; Treatment; Prevention: HPV vaccines.



Allergens and respiratory pollutantsThe role of innate immunityEdited by M A Williams, United States Environmental Protection Agency, USA


Allergens and respiratory pollutants is a collection of 12 authoritative papers that draws upon the collective expertise of world leaders in the fields of innate immunity, immunotoxicology and pulmonary biology. The book critically explores the biological and immunological mechanisms that contribute to immune dysfunction on exposure to allergens and the susceptibility to infectious disease on exposure to ambient pollutants. The clinical relevance of exposure to ambient airborne xenobiotics is critically discussed and collectively, this book provides an educational forum that links the health effects of environmental exposures, immune dysfunction and inflammatory airways disease.

CONTENTSAn introduction to allergic inflammation and the innate immune sensing of dangerous ambient pollutants by the dendritic cell; Asthma: Primary immunomodulatory pathways; Environmental lung injury and pattern recognition receptors; Asthma exacerbations: A paradigm of synergy between allergens, pollutants and viruses; Bronchial hyperresponsiveness and lung inflammation induced by allergic immune response and oxidative stress: Role of innate and adaptive immune responses; Effects of air pollutants on allergic sensitization through the airway; Particulate matter and oxidative stress: Dangerous partners in inflammation, vascular dysfunction and innate immunity; Diesel exhaust particles and the airway epithelial cell–dendritic cell interface in the control of immune homeostasis; Role of macrophages in adverse pulmonary effects of particulate pollutants; Particulate air pollution and vulnerability to respiratory infections in children; The intersection of respiratory syncytial virus infection, innate immunity and allergic lung disease; Interactions between allergens and dendritic cells: Pattern recognition receptors and their function in the pathogenesis of allergic respiratory diseases.



NANOSCIENCE AND TECHNOLOGY IN MEDICINE

Nanoparticulate drug deliveryPerspectives on the transition from laboratory to marketV Patravale, Institute of Chemical Technology, India, P Dandekar and R Jain, Institute of Chemical Technology, India


Nanoparticulate drug delivery highlights and examines the transition of nanoparticulate drug delivery systems, operating at scales of billionths of a metre, from laboratory into a commercially viable sector. This has been a challenging journey, beginning in 2005 with the introduction of Abraxane, the first nanotechnology-based drug delivery product for the treatment of breast cancer, which marked the advent of nanotechnology in the pharmaceutical and healthcare industry. The book describes the need for various types of nanoparticulate drug delivery systems in different application areas, and assesses the challenges associated with their advance to society.

CONTENTSNanoparticulate systems as drug carriers: the need; Nanoparticles as drug carriers; Characterization techniques for nanoparticulate carriers; Nanotoxicology: evaluating toxicity potential of drug-nanoparticles; Regulatory aspects of nanoparticulate drug delivery systems; Clinical trials and industrial aspects; Case studies: nano-systems in the market.



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Nanoparticle-based approaches to targeting drugs for severe diseasesJ L Arias, University of Granada, Spain


Nanoparticle-based approaches to targeting drugs for severe diseases is devoted to the analysis of the latest developments in the use of passive and/or active targeting nano-strategies for controlling the biodistribution profiles of pharmacotherapy agents. Special attention is given to recent advances in these engineering approaches: specifically, to target nanomedicines against severe diseases, and to the development of multifunctional nanoplatforms for combined selective diagnosis and effective pharmacotherapy. This book provides an in-depth and detailed analysis of the above problems, and a comprehensive discussion of the available solutions. It focuses on aspects of the formulation of drug nanocarriers, alongside characterisation techniques, toxicity issues, regulatory aspects, and marketing.

CONTENTSIntegration of nanotechnology in pharmacotherapy; Nanostructures in drug delivery; Nano-engineering strategies for passive drug delivery and targeting; Nano-engineering strategies for ligand-mediated drug delivery and targeting; Nano-engineering strategies for stimuli-sensitive drug delivery and targeting; Nano-engineering strategies in theragnosis; Advanced nanomedicines against severe diseases.



PHARMACEUTICAL SCIENCE/TECHNOLOGY, DRUG DELIVERY

Clinical research in paediatric psychopharmacologyA practical guideP Auby, Corporate ICR France & Paediatrics, France


Clinical research in paediatric psychopharmacology covers ethical, regulatory, clinical, scientific, intercultural and practical aspects of clinical research in child and adolescent psychopharmacology. The book is written and organised with the aim of being a practical guide, providing both an overview of clinical research in paediatric psychopharmacology and practical points to consider when developing clinical research in this field.

CONTENTSHistorical perspective; Regulatory changing environment - US; EU; and WHO; Scientific - state of the art - child and adolescent psychopharmacology at the beginning of the 21st century; Ethical aspects of research in paediatric psychopharmacology; Clinical development; Patients and family perspectives; Intercultural aspects; Future methodological perspectives; Future of child and adolescent psychopharmacological research.



RNA interferenceTherapeutic developmentsT Novobrantseva, Meena, P Ge and G Hinkle, Alnylam Pharmaceuticals, USA


RNA interference, written by leading researchers in the field, covers selection of siRNA, screening for the active molecules, general considerations in introducing chemical modifications, as well as discussing formulations used to deliver siRNA and applications of RNAi in many exciting therapeutic areas.

CONTENTSBiology and history of RNAi; Ways of introducing RNAi into mammalian cells; Designing potent and specific synthetic siRNA; Chemistry of siRNA molecules; Issue of delivery; Delivery methods; Clinical application of siRNA.



Clinical trial managementAn overviewU Sahoo, India for Chiltern and D Sawant, Clinical Monitoring, India


Clinical trial management is designed to show the various activities that are involved in clinical trials and understand their processes, which are essential for planning and implementing a successful clinical trial. This book also facilitates the understanding of the importance of ethics in clinical studies and the evolution of various guidelines, rules and regulations for the management of a clinical trial. Recruitment and retention of valuable patients are critical to the success of a clinical trial and hence pose a large number of challenges for the management team to complete the trial in multiple countries with the desired number of patients enrolled in time.

CONTENTSProject management; Inspection and audits; Regulatory affairs; Pharmacovigilance; Medical affairs; Patient recruitment and retention; Ethics in clinical research.



Formulation tools for pharmaceutical developmentEdited by J E A Diaz


The tools included in this book are: expert systems; artificial intelligence tools, neuro-fuzzy tools, multimedia tools, artificial neural networks, neurofuzzylogic and genetic programming, plus other mathematical tools.

CONTENTSGeneral introduction to pharmaceutical development in the regulatory environment (New ICH Q8; Existing expert systems for product formulation; SeDeM expert system for development of tablets by direct compression; SeDeM-ODT expert system for development of ODT (Orally Disintegrating Tablet) by direct compression; Capsugel expert System; Oxpirt expert system; UBasel expert system; Artificial intelligence; ME_expert 2.0 a heuristic decision support system for microemulsions formulation development; Intelligence technology; Tool for optimization of roller compactor process; Expert system for development of push-pull osmotic pump tablets containing poorly water-soluble drugs; Tools for the minimization of the capping tendency by tablet process; Conclusion.



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The life-cycle of pharmaceuticals in the environmentR Braund and B M Peake, University of Otago, New Zealand


The life-cycle of pharmaceuticals in the environment identifies pathways of entry of pharmaceuticals into the environment - beginning with the role of global prescribing and disposal practices. It then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and potable water. Methods currently available to degrade pharmaceuticals in the natural waters are discussed and then some of their ecotoxicological impacts are reviewed. Future considerations and the growing concept of ‘product stewardship’ are also examined.

CONTENTSPrescribing practices of pharmaceuticals; Disposal practices of pharmaceuticals; Pharmaceutical levels detected within natural waters; Removal and degradation of pharmaceuticals in natural waters; Environmental impact; Conclusions/future policies.



Orphan drugsUnderstanding the rare disease market and its dynamicsE Hernberg-Stahl, Late Phase Solutions Europe AB, Sweden


This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe. Before the orphan drug legislation enacted in the US in 1983, there was a limited interest from industry to develop treatment for very small patient groups. One of the difficulties is, of course, that similar levels of investment are needed from a pharmaceutical company to bring a drug to the market for both small and large patient groups.

CONTENTSWhat is an orphan drug? Orphan drug legislation; Patient network and advocacy groups; Organizations and networks dedicated and contributing to the dissemination of knowledge about rare diseases and orphan drugs; US Congress/ EU Commission initiated collaborative activities; Designing robust clinical trials for orphan drugs.



Ocular transporters and receptorsTheir role in drug deliveryA K Mitra, University of Missouri, USA


Ocular transporters and receptors contains detailed descriptions of major transporters and receptors expressed in the eye, with special emphasis on their role in drug delivery. The complex anatomy and the existence of multiple barriers in the eye pose a considerable challenge to successful drug delivery to the eye. Hence ocular transporters and receptors are important targets for drug delivery. A significant advancement has been made in the field of ocular transport research and their role in drug delivery. In this book the cutting edge research being carried out in this field is compiled and summarized. The key areas the book focuses on include, the anatomy and physiology of the eye, biology of ocular transporters and receptors, techniques in characterization of transporters and receptors, transporters and receptors in the anterior and posterior segment in the eye, the role of ocular transporters and receptors in drug delivery, and transporter-metabolism interplay in the eye.

CONTENTSEye: Anatomy, physiology and barriers to drug delivery; Biology of ocular transporters and receptors; Characterization of ocular transporters and receptors; Transporters and receptors in the anterior segment of the eye; Transporters and receptors in the posterior segment of the eye; Transporters in subcellular organelles: Regulation, characterization and role in ocular drug delivery; Transporters in drug discovery and delivery: A new paradigm in ocular drug design; Transporter-metabolism interplay in the eye.



Drug-biomembrane interaction studiesThe application of calorimetric techniquesEdited by R Pignatello, University of Catania, Italy


Drug-biomembrane interaction studies is written by scientists renowned for their work in the field of DSC applications to drug development and delivery, and especially to drug-biomembrane interaction studies. The issues above are clarified, and any areas where uncertainties remain will be highlighted and assessed. The book combines insights from biochemistry and physiology with those from structural biology, nanotechnology and bio-thermodynamics, to obtain a complete depiction of cell membranes and their functions.

CONTENTSBiological membranes in physio-pathological conditions; Development of biomembrane models; Drug-biomembrane interactions and analytical methods (especially in combination with DSC) DSC: Theoretical bases; DSC: History, instruments and devices; DSC studies in the evaluation of drug-biomembrane interaction: A general overview; Literature review of the applications of DSC to study the interaction of specific classes of drugs with biomembrane models.



Therapeutic risk management of medicinesA K Banerjee and S Mayall, Pope Woodhead & Associates, UK


Therapeutic risk management of medicines is an authoritative, and yet practical guide on planning, writing, implementing and evaluating risk management plans for medicines globally. Chapters are also included on the historical development, lessons from other industries, the regulatory and health authority perspective and public communication of benefit risk.

CONTENTSIntroduction and historical background of risk management plans; EU-RMP (Risk Management Plan); USA REMS (Risk Evaluation and Mitigation Strategies); Safety specification; Pharmacovigilance planning; Assessing the need for risk minimization; Risk minimization tools; Implementation of RMPs and REMS; Evaluation of RMPs and REMS; Developmental risk management plans; Effectively negotiating with the health authorities; Public communication of benefit risk.



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Transporters in drug discovery and developmentDetailed concepts and best practiceL Lai, A major US pharmaceutical company, USA


Transporters in drug discovery and development provides a comprehensive and practical guide to drug transporter families that are the most important for drug discovery and development.

CONTENTSGeneral introduction of membrane transporter families (SLC and ABC); Multidrug resistance protein; Organic anion transporting polypeptides; Organic anion transporters; Organic cation transporters; Bile acid transporters; Enzyme-drug transporter interplay; Use of immortalized cell line or gene engineered expression tools to assess transporter interactions; Use of primary isolated human cells to assess transporter interactions; In vitro/in vivo, in vivo/in vivo translations of drug transporter activities.



Process validation for the production of biopharmaceuticalsPrinciples and best practiceA R Newcombe, Pfizer Biotechnology, Ireland and P Thillaivinayagalingam, Novartis Pharma S.A.S, France


Process validation for the production of biopharmaceuticals examines the practical, theoretical and regulatory aspects of process validation relevant to biopharmaceutical production and critically evaluates individual manufacturing unit operations. Chapters provide validation solutions applicable to a variety of commercial biopharmaceutical processes. The text includes a description of validation strategies and aspects of regulatory compliance with industry-focused practical examples. This book considers risk management strategies used for the selection of critical and key process parameters, along with the methodology used to categorise process outputs and define validation acceptance criteria.

CONTENTSThe Validation Master Plan (VMP); Process characterisation; Quality risk management; Buffer stability; Validation support studies; Cell culture (upstream); Drug product validation; Evaluating validation success post PV batch review and data analysis; Process analytics.



Computer-aided applications in pharmaceutical technologyEdited by J Djuris, University of Belgrade, Serbia


Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology and chemometric methods with emphasis on their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology.

CONTENTSQuality by design in pharmaceutical development; Computer-aided formulation development; Experimental design application and interpretation in pharmaceutical technology; Chemometric methods application in pharmaceutical process analysis and control; Neural computing in pharmaceutical products and process development; Computer aided biopharmaceutical characterization; Computational fluid dynamics in pharmaceutical technology.



Nanoparticle-based approaches to targeting drugs for severe diseasesJ L Arias, University of Granada, Spain


Nanoparticle-based approaches to targeting drugs for severe diseases is devoted to the analysis of the latest developments in the use of passive and/or active targeting nano-strategies for controlling the biodistribution profiles of pharmacotherapy agents. Special attention is given to recent advances in these engineering approaches: specifically, to target nanomedicines against severe diseases, and to the development of multifunctional nanoplatforms for combined selective diagnosis and effective pharmacotherapy.

CONTENTSIntegration of nanotechnology in pharmacotherapy; Nanostructures in drug delivery; Nano-engineering strategies for passive drug delivery and targeting; Nano-engineering strategies for ligand-mediated drug delivery and targeting; Nano-engineering strategies for stimuli-sensitive drug delivery and targeting; Nano-engineering strategies in theragnosis; Advanced nanomedicines against severe diseases.



Therapeutic antibody engineeringCurrent and future advances driving the strongest growth area in the pharma industryW R Strohl, Johnson & Johnson Biotechnology Center of Excellence and L M Strohl, Medical Illustrator, USA


Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on candidates of the future. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. In the following chapters, the book covers a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering.

CONTENTSIntroduction to biologics and monoclonal antibodies; Value proposition for therapeutic monoclonal antibodies and Fc fusion proteins; Antibody structure–function relationships; Fundamental technologies for antibody engineering; Sources of antibody variable chains; Variable chain engineering – humanization and optimization approaches; Antibody interactions with the immune system; Monoclonal antibody targets and mechanisms of action; Therapeutic antibody classes; Antibody Fc engineering for optimal antibody performance; IgG glycans and glyco-engineering; Antibody fragments as therapeutics; Multiple antibody and multi-specificity approaches; Fc fusion proteins and similar constructs using Fc; Antibody-drug conjugates; Development issues: Antibody stability, developability, immunogenicity, and comparability; Interactions of human IgGs with non-human systems; Cell line development; Issues facing therapeutic monoclonal antibodies for the future.



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Clinical research in AsiaOpportunities and challengesU Sahoo, Chiltern, India


Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis).

CONTENTSClinical research in Asia; Clinical research in Japan; Clinical research in China; Clinical research in India; Clinical research in Taiwan; Clinical research in South Korea; Clinical research in Singapore; Clinical research in Thailand; Clinical research in Philippines; Clinical research in Malaysia; Clinical research in Vietnam.



Therapeutic protein drug productsPractical approaches to formulation in the laboratory, manufacturing, and the clinicEdited by B K Meyer, Merck Research Laboratories (MRL), USA


Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration.

CONTENTSCommercial therapeutic protein drug products; A formulation method to improve the physical stability of macromolecular-based drug products; Properties of protein formulations; Material and process compatibility testing; Compounding and filling: Drug substance to drug product; Administration in the clinic; Regulatory guidelines for the development of a biotechnology drug product.



An introduction to pharmaceutical sciencesProduction, chemistry, techniques and technologyJ Roy, Mississippi University for Women, USA


This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences.

CONTENTSCareer prospects in the pharmaceutical industry; Drugs, medicines, and regulatory authorities; Bulk drugs or active pharmaceutical ingredients; Formulated drugs 1; Formulated drugs 2; The stability of medicines; Quality assurance in medicines; Pharmacological concepts and drugs; The top five most common or long-selling drugs; Life-style drugs, statins, and COX-2 drugs; Counterfeit drugs and drug abuse; New pharmaceutical technology and pharmaceuticals; Future prospects for the pharmaceutical industry; Pharmaceutical case studies.

446 pages 234 x 156mm (6 x 9) paperback 2011ISBN: 978 1 907568 52 7 E-ISBN: 978 1 908818 04 1


REGENERATIVE MEDICINE

Developments in tissue engineered and regenerative medicine productsA practical approachJ Basu and J W Ludlow, Tengion Inc, USA

Woodhead Publishing Series in Biomaterials No. 48

Developments in tissue engineered and regenerative medicine products summarizes recent developments in tissue engineering and regenerative medicine with an emphasis on commercialization and product development. Features of current cell therapy and tissue engineered products which have facilitated successful commercialization are emphasized. Roadblocks to successful product development are also highlighted. Preclinical and clinical testing of tissue engineered and regenerative medicine products, regulatory, quality control, manufacturing issues, as well as generating and securing intellectual property and freedom to operate considerations are presented. This book represents a complete ‘how-to’ manual for the development of tissue engineered and regenerative medicine products from conceptualization to clinical trial to manufacturing.

CONTENTSOverview of tissue engineering/regenerative medicine; Cells; Biomaterials for TE/RM products; Neo-Bladder: A foundational technology platform for tubular organ regeneration; Neo-Urinary Conduit™; Tissue engineering of non-bladder tubular organs; Tissue engineering of solid organs; Regulatory and quality control; Pre-clinical and clinical evaluation of TE/RM products; Manufacturing; Intellectual property.



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STEM CELL SCIENCES

Stem cell bioprocessingFor cellular therapy, diagnostics and drug developmentT G Fernandes, M M Diogo and J M S Cabral, Instituto Superior Técnico (IST), Technical University of Lisbon, Portugal


Stem cell bioprocessing describes the main large-scale bioprocessing strategies for both stem cell culture and purification, envisaging the application of these cells for regenerative medicine and drug screening. Bioreactor configurations are described, including their applications for stem cell expansion and/or differentiation. Stem cell separation techniques are also discussed, aiming towards both isolation and purification of rare stem cell populations.

CONTENTSStem cells; Stem cell culture; Bioreactors for stem cell culture; Stem cell bioseparation; Micro-scale technologies for stem cell culture and separation; Stem cells and regenerative medicine.



Commercializing the stem cell sciencesO Harvey, University of Sydney, Australia


Commercializing the stem cell sciences offers a comparative analysis of the commercial methods adopted in the global stem cell industries, and seeks to establish whether there is an optimum commercial model, and to examine what emerging companies can learn from their predecessors. The book begins with a discussion of stem cell treatments from a global perspective, and the role of innovation in the commercialization of biotechnology in general. In the second half of the book, chapters focus on the different strategies that can be employed and their relative risks and values, before a conclusion that looks at potential new developments in the field.

CONTENTSIntroduction: Stem cell science, biotechnology and the problem of commercialization; Stem cell treatments in a global marketplace; The role of innovation systems in the commercialization of biotechnology; Low-risk, low value strategies: Adult stem cells; High-risk, high-value: embryonic stem cells; Low-risk, low-value: iPS cells; Conclusion: What will happen next?



APPLICATIONS

Nanomaterials in tissue engineeringCharacterization, fabrication and applicationsEdited by A K Gaharwar, Harvard Medical School and Massachusetts Institute of Technology, S Sant, University of Pittsburgh and Harvard Medical School, M J Hancock, Broad Institute and S A Hacking, Massachusetts General Hospital, USA


Nanomaterial technologies can be used to fabricate high-performance biomaterials with tailored physical, chemical, and biological properties. Nanomaterials are therefore currently the development focus for emerging biomedical technologies such as scaffolding, tissue regeneration, and controlled drug delivery. This important volume will provide readers with a thorough overview of this developing field. The first set of chapters review the fundamentals of nanomaterials for medical applications. Another group of chapters cover the fundamentals of nanomaterials for tissue engineering. Further chapters look at applications of nanomaterials in soft tissue engineering whilst the final set of chapters will review applications of nanomaterials in hard tissue engineering.

CONTENTSPart 1 Fundamental of nanomaterials in tissue engineering: Biomedical nanomaterials for tissue engineering; Physiochemical characterization of biomedical nanomaterials. Part 2 Fabrication of nanomaterials for tissue engineering applications: Synthesis of polymeric nanomaterials for biomedical applications; Methods for nano and microtopological patterning in biomaterials engineering; Multilayered films in tissue engineering; Carbon based nanomaterials for tissue engineering; Nanofibrous scaffolds for drug delivery and tissue engineering; Nanomaterials for growth factor delivery in tissue engineering applications. Part 3 Application of nanomaterials in soft tissue engineering: Nanomaterials for engineering vascularized tissue; Nanomaterials for cardiac tissue engineering; Nanomaterials for cartilage tissue engineering; Nanomaterials for ligament tissue engineering. Part 4 Application of nanomaterials in hard tissue engineering: Nanomaterials for hard-soft tissue interfaces; Nanomaterials for bone tissue engineering; Nanomaterials for dental and craniofacial tissue engineering.



NanomedicineTechnologies and applicationsEdited by T J Webster, Brown University, USA


Nanotechnology is at the forefront of advances in medicine. Nanomedicine: Technologies and applications provides an important review of this exciting technology and its growing range of applications. Part one discusses key materials and their properties, including nanocrystalline metals and alloys, nanoporous gold and hydroxyapatite coatings. Part two goes on to review nanomedicine for therapeutics and imaging. Nanomedicine for soft tissue engineering is discussed in part three, including organ regeneration, skin grafts, nanotubes and self-assembled nanomaterials. Finally, nanomedicine for bone and cartilage tissue engineering is the focus of part four, with electrically active biocomposites for smart scaffolds investigated alongside cartilage and bone tissue engineering, regeneration and replacement.

CONTENTSPart 1 Materials, properties and considerations: Introduction to nanomedicine; Trends in nanomedicine; Biomedical nanocrystalline metals and alloys: Structure, properties and applications; Nanoporous gold for biomedical applications: Structure, properties and applications; Hydroxyapatite (HA) coatings for biomaterials. Part 2 Nanomedicine for therapeutics and imaging: Calcium-phosphate coated magnetic nanoparticles for treating bone diseases; Orthopaedic carbon nanotube biosensors for controlled drug delivery; Nanostructured selenium anti-cancer coatings for orthopaedic applications; Nanoparticulate targeted drug delivery using peptides and proteins; Nanotechnology for DNA and RNA delivery; Gold nanoshells for imaging and photothermal ablation of cancer; Microfluidics for testing and delivering nanomedicine; Zinc oxide nanowires for biomedical sensing and analysis. Part 3 Nanomedicine for soft tissue engineering: Nanotechnology and tissue engineered organ regeneration; Rapid fabrication of biomimetic nanofiber-enabled skin grafts; Nanotubes for tissue engineering; Self-assembled nanomaterials for tissue engineering applications. Part 4 Nanomedicine for bone and cartilage tissue engineering: Electrically active biocomposites for smart scaffolds for bone tissue engineering; Nanotechnology for cartilage and bone regeneration; Nanostructured materials for bone tissue replacement; Nanocomposites for cartilage regeneration.



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Inhaler devicesFundamentals, design and drug deliveryEdited by P Prokopovich, University of Cardiff, UK


Inhaler devices are vital to the well-being of numerous asthma sufferers and are therefore continually being developed and improved. This book discusses the history of inhalers and will provide readers with an introduction to the fundamentals, followed by discussions on research & development. Chapters in the first part of the book look at the fundamentals of the in vitro environment and design of inhaler devices. Chapters in the final part of the book review a wide variety of nanomaterials for drug delivery through inhalers. This book will be a useful design guide for good industrial practice and development.

CONTENTSPart 1 Fundamentals and design of inhaler devices: Anatomy and pathophysiology of the respiratory system; History of therapy development: From jet nebulisers to pMDIs; Process development and Scale–up; Tribology of inhaler devices and its components; Microbial control and safety in inhalation devices. Part 2 Nanomaterials for drug delivery: Formulating drugs for inhalers and stability issues; Bioadhesive chitosan polymers for pulmonary drug delivery; Multilayers, nanocapsules, and multicapsules for drug storage and delivery; Functionalized core-shell nanoparticles for medical applications; Biomolecules and vaccines in pMDIs; Pulmonary gene delivery.



Drug-device combination productsDelivery technologies and applicationsEdited by A Lewis, Biocompatibles UK Ltd, UK

Woodhead Publishing Series in Biomaterials No. 22CONTENTSPart 1 Overview: Drug-device combination products; Enabling drug delivery from combination products; Nanomedical drug-device combination products. Part 2 Areas of application: Catheter-based drug-device combination products: An overview; Catheter-based drug-device combination products: The anti-infective 5-fluorouracil-coated central venous catheter; Future outlook for drug eluting stents (DES); Drug eluting beads (DEB) in the treatment of liver cancer; Antibiotic-loaded bone cements; Glass-ionomer cements as drug-device combination products; Bone graft substitutes as drug-device combination products; Antibacterial releasing dental restorative materials; Collagen-based dressings as therapeutic agents for wound healing; Drug-device combination products for occular applications. Part 3 Development of drug-device combination products: Safety and efficacy issues in designing drug-device combination products: The case of drug eluting stents (DES); Preclinical testing of drug-device combination products; Sterilisation of drug-device combination products; Innovation and patent issues in the development of drug-device combination products: The case of drug eluting stents (DES); Regulation of drug-device combination products in Europe; (28a) Regulation of drug-device combination products in the USA.



Standardisation in cell and tissue engineeringMethods and protocolsEdited by V Salih, University College London, UK


The ‘promises’ and objectives of tissue engineering proposed some 30 years ago have not delivered the numerous products and synthetic therapies for most of the tissue requirements of diseased or traumatised tissues. This may be due to the lack of standardisation during the induction, development, and maintenance of differentiation within cells and tissue matrices under in vitro conditions. This book brings together standard methods and protocols for these therapies with a view to bringing more products more speedily to the market. Chapters in the first part of the book discuss methods for standardising cell and tissue engineering applications whilst the final group of chapters discuss the protocols surrounding cell and tissue engineering.

CONTENTSPart 1 Methods in standardisation of cell and tissue engineering: Fundamentals of cell and matrix biology; Biomatrix development; New concepts and therapies in cell engineering; Synthetic materials development; 2D/3D tissue culture methods for soft tissues; 2D/3D tissue culture methods for hard tissues; Standards in physical therapies. Part 2 Protocols in standardisation of cell and tissue engineering: Quality control; Sterilisation procedures; Standardising methods and regulatory Issues; Standardization of protocols for global manufacture.



Biomaterials for artificial organsEdited by M Lysaght and T Webster, Brown University, USA


‘Undoubtedly a useful resource, it would be well placed in the biotechnology section of any university library.’

Materials World

CONTENTSPart 1 Commodity biomaterials: Membranes for oxygenators and plasmafilters: Titanium and cobalt-chromium alloys for hips and knees; Polymeric joint bearing surfaces for total joint replacements; Biomaterials for pacemakers, defibrillators and neurostimulators; Mechanical and bioprosthetic valves. Part 2 Advanced and next generation biomaterials: Small intestinal submucosa and other decullarized matrix biomaterials for tissue repair; New ceramics and composites for joint replacement surgery; Biomaterials for improving the blood and tissue compatibility of Total Artificial Hearts (TAH) and Ventricular Assist Devices (VAD); Nanostructured biomaterials for artificial tissues and organs; Matrices for tissue engineering and regenerative medicine.



Biomaterials in plastic surgeryBreast implantsEdited by W Peters, University of Toronto, Canada, H Brandon, K L Jerina, Washington University in St Louis, C Wolf, formerly Washington University in St Louis and V L Young, BodyAesthetic Plastic Surgery and Skincare Center, USA


Biomaterials in plastic surgery reviews the history, materials and safety issues associated with breast implants. Beginning with an introduction to the history of biomaterials used for breast augmentation, the book goes on to discuss development issues. It then discusses the chemistry and physical properties of biomedical silicones before reviewing cohesive gel and polyurethane foam implants. The book concludes by analysing the epidemiological evidence on the safety issues relating to breast implants, followed by a review of retrieval and analysis of breast implants emphasizing strength, durability and failure mechanisms.

CONTENTSThe history of biomaterials used for breast augmentation; The development of breast implants; The chemistry and physical properties of biomedical silicones; Cohesive gel breast implants; Polyurethane foam breast implants; The safety of breast implants: Recent epidemiological studies; Failure modes of breast implants.



Biomaterials for treating skin lossEdited by D P Orgill, Brigham and Women’s Hospital and C Blanco, Joseph M. Still Research Foundation, USA

Woodhead Publishing Series in Biomaterials No. 17CONTENTSPart 1 Introduction: Development of skin substitutes; Skin replacement products and markets; Biomechanics of skin; The pathophysiologic basis for wound healing and cutaneous regeneration; Skin grafts; Understanding the cellular basis of skin growth; The regulatory approval process for biomaterials for treating skin loss. Part 2 Epidermal and dermal replacement technologies: Enhancing skin epidermal stability; Human-derived acellular matrices for dermal replacement; Lyophilized xenogenic products for skin replacement. Part 3 Combined dermis and epidermal replacement: Cultured skin substitutes; The use of keratinocytes in combination with a dermal replacement to treat skin loss; Principles of skin regeneration; Summary: biomaterials for treating skin loss.



Biomaterials

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Advanced wound repair therapiesEdited by D Farrar, Smith and Nephew, UK


Wound repair is an important and lucrative sector of the medical industry. Consequently, significant and increasingly sophisticated biomaterials and strategies are continuously being developed. Advanced wound repair therapies provides readers with up-to-date information on fundamental, emerging and cutting-edge biomaterials concerned with healing internal and external surgical and traumatic wounds. Part one provides readers with an introduction to chronic wounds. Part two analyses therapies for chronic wounds. Chapters in part three discuss molecular therapies for chronic wounds whilst part four reviews biologically-derived and cell-based therapies for chronic wounds. The final group of chapters cover physical stimulation therapies for chronic wounds.

CONTENTSPart 1 Introduction to chronic wounds: Dysfunctional wound healing in chronic wounds; The role of micro-organisms and biofilms in dysfunctional wound healing; Scarring and scarless wound healing; The discovery and development of new therapeutic treatments for the improvement of scarring; Monitoring chronic wounds and determining treatment. Part 2 Biomaterial therapies for chronic wounds: Functional requirements of wound repair biomaterials; Tissue-biomaterial interaction; Polymeric materials for chronic wound and burn dressings; Dry wound healing concept using spray-on dressing for chronic wounds; Assessing the effectiveness of antimicrobial wound dressings in vitro; Adhesives and interfacial phenomena in wound healing; Wound healing studies and interfacial phenomena: Use and relevance of the corneal model; Sulphonated biomaterials as glycosaminoglycan mimics in wound healing. Part 3 Molecular therapies for chronic wounds: Drug delivery dressings; Molecular and gene therapies for wound repair; Antimicrobial dressings; Avotermin: emerging evidence of efficacy for the improvement of scarring. Part 4 Biologically-derived and cell-based therapies for chronic wounds: Engineered tissues for wound repair; Commercialisation of engineered tissue products; Biologically derived scaffolds; Stem cell therapies for wound repair. Part 5 Physical stimulation therapies for chronic wounds: Electrical stimulation for wound healing; Negative pressure wound therapy; Debridement methods of non-viable tissue in wounds.



Joint replacement technologyEdited by P A Revell, University College London, UK

Woodhead Publishing Series in Biomaterials No. 11CONTENTSPart 1 Introduction. Part 2 Material and mechanical issues. Part 3 The device biological environment. Part 4 Specific joints: Hip replacement.



Biomaterials for spinal surgeryEdited by L Ambrosio, Università di Napoli Federico II, Italy and E Tanner, University of Glasgow, UK


There have been important developments in materials and therapies for the treatment of spinal conditions. Biomaterials for spinal surgery summarises this research and how it is being applied for the benefit of patients. After an introduction to the subject, part one reviews fundamental issues such as spinal conditions and their pathologies, spinal loads, modelling and osteobiologic agents in spinal surgery. Part two discusses the use of bone substitutes and artificial intervertebral discs whilst part three covers topics such as the use of injectable biomaterials like calcium phosphate for vertebroplasty and kyphoplasty as well as scoliosis implants. The final part of the book summarises developments in regenerative therapies such as the use of stem cells for intervertebral disc regeneration.

CONTENTSIntroduction to biomaterials for spinal surgery. Part 1 Fundamentals of biomaterials for spinal surgery: An overview of the challenges of bringing a medical device for the spine to the market; Introduction to spinal pathologies and clinical problems of the spine; Forces on the spine; Finite element modelling of the spine; Osteobiologic agents in spine surgery. Part 2 Spinal fusion and intervertebral discs: Spine fusion: cages, plates and bone substitutes; Artificial intervertebral discs; Biological response to artificial discs. Part 3 Vertobroplasty and scoliosis surgery: The use of polymethyl methacrylate (PMMA) in neurosurgery; Optimising the properties of injectable materials for vertebraplasty and kyphoplasty; Injectable calcium phosphates for vertebral augmentation; Composite injectable materials for vertebroplasty; Scoliosis implants: surgical requirements; Shape memory, superelastic and low Young’s modulus alloys. Part 4 Regenerative medicine in the spine: Cell-based tissue engineering approaches for disc regeneration; Angiogenesis control in spine regeneration; Stem cells for disc regeneration; Nucleus regeneration; In vivo models of regenerative medicine in the spine.



Biomaterials and tissue engineering in urologyEdited by J Denstedt, University of Western Ontario, Canada and A Atala, Wake Forest Institute for Regenerative Medicine, USA

Woodhead Publishing Series in Biomaterials No. 18CONTENTSPart 1 Fundamentals. Part 2 Materials and design of urological devices. Part 3 Urological tissue engineering.



Regenerative medicine and biomaterials for the repair of connective tissuesEdited by C Archer and J Ralphs, Cardiff University, UK

Woodhead Publishing Series in Biomaterials No. 24CONTENTSStructure and regenerative capacity of synovial joint tissues; The myofibroblast in connective tissue repair and regeneration. Part 1 Cartilage repair and regeneration: Structure of articular cartilage; Measuring the biomechanical properties of cartilage cells; Understanding tissue response to cartilage injury; Understanding osteoarthritis and other cartilage diseases; Using animal models of cartilage repair to screen new clinical techniques; Cartilage tissue repair: autologous osteochondral mosaicplasty; Cartilage tissue repair: Autologous chondrocyte implantation; Cell sheet technologies for cartilage repair; Cell therapies for articular cartilage repair: Chondrocytes and mesenchymal stem cells; Scaffolds for musculoskeletal tissue engineering; Outcome measures of articular cartilage repair. Part 2 Repair of tendons and ligaments: The structure of tendons and ligaments; Tendon biomechanics; Tendon injury and repair mechanisms; Tissue engineering for ligament and tendon repair; Cell-based therapies for the repair and regeneration of tendons and ligaments; Scaffolds for tendon and ligament tissue engineering.



Biomaterials and regenerative medicine in ophthalmologyEdited by T V Chirila, Queensland Eye Institute, Australia

Woodhead Publishing Series in Biomaterials No. 23CONTENTSAn introduction to ophthalmic biomaterials and their application through tissue engineering and regenerative medicine. Part 1 Applications in the anterior segment: Advances in intraocular lens development; Opacification and degradation of implanted intraocular lenses; Synthetic corneal implants; Corneal tissue engineering versus synthetic artificial corneas; Tissue engineering of human cornea; Engineering the corneal epithelial cell response to materials; Reconstruction of the ocular surface using biomaterials; Tissue engineering of the lens: Fundamentals; Bioinspired biomaterials for soft contact lenses; Contact lenses: The search for superior oxygen permeability; Extended wear contact lenses. Part 2 Applications in the posterior segment: Designing hydrogels as vitreous substitutes in ophthalmic surgery; Retinal repair and regeneration; Development of tissue-engineered membranes for the culture and transplantation of retinal pigment epithelial cells. Part 3 Other applications: Hydrogel sealants for wound repair in ophthalmic surgery; Orbital enucleation implants: Biomaterials and design; Selected polymeric materials for orbital reconstruction; Physicochemical properties of hydrogels for use in ophthalmology.



Biomaterials

NEW


Bone repair biomaterialsEdited by Principal editor J A Planell, Institute for Bioengineering of Catalonia (IBEC), Spain, Section editors S M Best, University of Cambridge, UK, D Lacroix, Institute for Bioengineering of Catalonia (IBEC), Spain and A Merolli, The Catholic University in Rome, Italy


‘The book is beautifully referenced. Certain chapters are recommended for all orthopaedic surgeons... For a new researcher it is an invaluable introduction from start to finish.’

Journal of Bone and Joint Surgery

CONTENTSPart 1 Introduction: Challenges of bone repair; Bone anatomy, physiology and adaptation to mechanical loading; Bone repair and regeneration; Biomechanical aspects of bone repair. Part 2 Biomaterials: Properties and characterisation of bone repair materials; Metals as bone repair materials; Ceramics as bone repair materials; Polymers for bone repair; Composite biomaterials for bone repair; Cements as bone repair materials; Bioactive polymer coatings to improve bone repair; Long-term performance and failure of orthopaedic devices. Part 3 Clinical applications: Using bone repair materials in orthopaedic surgery; Bone tissue engineering; Retrieval and analysis of orthopaedic implants; Ethical issues in bone repair and bone tissue engineering.



Orthopaedic bone cementsEdited by S Deb, King’s College London, UK


CONTENTSPart 1 Bone cements in medicine: Bone disease; Hip replacements; Knee replacements; Vertebroplasty and kyphoplasty; Antibiotic-impregnated polymethyl-methacrylate (PMMA) spacers in hip surgery; Commercial aspects and delivery systems of bone cements; Wear particles and osteolysis. Part 2 Materials: Acrylic bone cement: Genesis and evolution; Poly(methylmethacrylate) bone cement: Chemical composition and chemistry; Calcium phosphate bone cements. Part 3 Properties of bone cements: Mechanical properties of bone cements; Fracture toughness and fatigue characteristics of bone cements; Dynamic creep in bone cements. Part 4 Enhancing the properties of bone cements; Antibiotic-loaded bone cements; Modifications of bone cements; Design of bioactive bone cement based on organic-inorganic hybrids; Clinical aspects of calcium phosphate bone cements.



Biomaterials and devices for the circulatory systemEdited by T Gourlay and R Black, University of Strathclyde, UK

Woodhead Publishing Series in Biomaterials No. 27CONTENTSPart 1 Physiological responses to biomaterials. Part 2 Clinical application of biomaterials. Part 3 Future developments.



Materials science for dentistryNinth editionB W Darvell, formerly University of Hong Kong, Hong Kong and now Professor in Dental Materials Science at Kuwait University, Kuwait.

Woodhead Publishing Series in Biomaterials No. 19CONTENTSMechanical testing; Gypsum materials; Polymers; Rheology; Acrylic; Resin restorative materials; Flexible impression materials; Composition and phase diagrams; Cements and liners; Surfaces; Metals I: Structure; Metals II: Constitution; Corrosion; Silver Amalgam; Mixing; Waxes; Casting investments; Casting; Casting alloys; Cutting, abrasion and polishing; Steel and cermet; Soldering and welding; Mechanics; Light and colour; Porcelain; Radiography; More polymers; More metals; More mechanical testing.

688 pages 280 X 210mm (8 x 11) paperback 2009ISBN: 978 1 84569 529 3 E-ISBN: 978 1 84569 667 2


Dental biomaterialsImaging, testing and modellingEdited by R V Curtis and T F Watson, King’s College London, UK

Woodhead Publishing Series in Biomaterials No. 10CONTENTSCharacterizing the performance of dental air-turbine handpieces; Optical imaging techniques for dental biomaterials interfaces; Electron microscopy for imaging interfaces in dental restorations; Dental adhesives and adhesive performance; Mechanical stability of resin-dentin bonds; Dental cements: Formulations and handling techniques; Mixed-methods approach to wear evaluation in posterior composite dental restorations; Shape optimisation of dental restorations; Fibre-reinforced composites for dental applications; Fracture mechanics characterisation of dental biomaterials; Modelling bond strength in dental biomaterials; Fracture and ageing of dentin; Finite element analysis of stresses in dental crowns; Testing the performance of dental implants; Superplastic forming of dental and maxillofacial prostheses; Dental investment materials for casting metals and alloys.



CLINICAL TECHNIQUES

Decontamination in hospitals and healthcareEdited by J Walker, Health Protection Agency, USA


Effective infection control in the healthcare sector is vital to public health, therefore methods to continually monitor and treat contamination are a major concern of governments around the globe. This unique book will bring an understanding of decontamination to a wider audience interested in public health, including healthcare specialists, scientists or patients. The first set of chapters provides readers with an introduction to decontamination in the international healthcare sector. A second set of chapters look at decontamination practises in hospitals and healthcare settings. The third group of chapters discuss decontamination of surgical equipment and endoscopes.

CONTENTSPart 1 Fundamentals of decontamination in hospitals and healthcare: The importance of decontamination in hospitals and healthcare; The history of decontamination in hospitals; Biofilms - problems in the healthcare setting and methods of control; The role of standards in decontamination; Infection control in Europe. Part 2 Decontamination practices in hospitals and healthcare: An overview of current decontamination practices of surgical instruments; Decontamination in primary care: dental and hospital perspectives; Decontamination in primary care - dental unit water systems and microbial control in dental hospitals; Control of waterborne microorganisms and reducing the threat from Legionella and Pseudomonas; Use of gaseous decontamination technologies for wards and isolation rooms in hospitals and healthcare settings; Biocides and Decontamination agents including sporicides for decontamination in hospitals; Cleaning for controlling health care associated infections (HCAIs); The role of protective clothing in healthcare and its decontamination; New technologies to control the presence of microorganisms in hospitals; Testing strategies and international standards for disinfectants; Decontamination of prions. Part 3 Decontamination of surgical instruments and endoscopes: An overview of choice framework for policies and protocols for decontamination; Efficacy of current and novel cleaning technologies (ID Box) for assessing protein contamination on surgical instruments; Decontamination and microbiological failures of endoscopes; The role of sterilisation in endoscopes.



Biomaterials

NEW


The hip resurfacing handbookA practical guide for the use and management of modern hip resurfacingsEdited by K De Smet, ANCA Clinic, Belgium, P Campbell, UCLA, USA and C Van Der Straeten, Consultant, Belgium


Surface arthroplasty (surface replacement) of the hip with metal-on-metal bearings is one of the fastest growing areas within the field of joint surgery. Chapters in part one provide readers with information on a wide range of hip resurfacing designs. Part two focuses on clinical follow-up to hip resurfacing. Part three discusses a variety of operative techniques whilst the final section provides readers with case studies and conclusions.

CONTENTSPart 1 Hip resurfacing designs: The ACCIS hip resurfacing prosthesis; The ADEPT® hip resurfacing prosthesis; The DePuy Articular Surface Replacement (ASR) hip resurfacing prosthesis; The Birmingham Hip Resurfacing (BHR) prosthesis; The Conserve® Plus hip resurfacing prosthesis; The CormetTM hip resurfacing prosthesis; The Durom hip resurfacing prosthesis; The ESKA hip resurfacing prosthesis; The ICON hip resurfacing prosthesis; The MRS Modular Hip Resurfacing prosthesis; The MIHR International® hip resurfacing prosthesis; The MITCH hip resurfacing prosthesis; The BIOMET RECAP hip resurfacing prosthesis; The ROMAX® hip resurfacing system; The Tornier DynaMoM hip resurfacing prosthesis; Design issues and comparison of hip resurfacing prostheses. Part 2 Clinical follow-up: Clinical follow-up of the hip resurfacing patient; Acoustic phenomena in hip resurfacing; Rehabilitation of patients after hip resurfacing; The use of radiography to evaluate hip resurfacing; The use of bone scintigraphy to evaluate hip resurfacing; The use of ultrasound to evaluate hip resurfacing; The use of Computerized Tomography (CT) to evaluate hip resurfacing; The use of magnetic resonance imaging (MRI) to evaluate hip resurfacing; The use of Positron Emission Tomography (PET) to evaluate hip resurfacing; The use of dual energy x-ray absorptiometry (DEXA) to evaluate hip resurfacing; The use of metal ion level measurements to evaluate hip resurfacing; The practical application of metal ion level measurement in evaluating hip resurfacing. Part 3 Operative techniques: Comparing surgical techniques in hip resurfacing; Surgical technique in hip resurfacing: The modified posterior approach; Surgical technique in hip resurfacing: The anterior approach; Tips and tricks for successful hip resurfacing; Surgical instruments in hip resurfacing; Anaesthesia in hip resurfacing; Revision surgery for failed hip resurfacing. Part 4 Failure modes in hip resurfacing; Retrieval studies showing failure modes in hip resurfacing; Case studies of femoral neck fractures in hip resurfacing; Case studies of femoral loosening and femoral head collapse in hip resurfacing; Case studies of acetabular loosening in hip resurfacing; Case studies of acetabular malposition and high wear in hip resurfacing; Case studies of suspected metal allergy in hip resurfacing. Part 5 General issues: The patient experience of hip resurfacing; Comparing hip resurfacing arthroplasty (HRA) and total hip arthroplasty (THA); The current regulatory status of hip resurfacing arthroplasty (HRA); Web sites relating to hip resurfacing.



Preprosthetic and maxillofacial surgeryBiomaterials, bone grafting and tissue engineeringEdited by J Ferri, Roger Salengro Hospital, France and E Hunziker, University of Bern, Switzerland


One of the most important factors in ensuring successful osseointegration is the stability of the implant after its insertion. In order to achieve optimum conditions for implantation, it is often necessary to prepare the area and reconstruct the bone to ensure that it is the correct shape and size for the implant. Preprosthetic and maxillofacial surgery provides a thorough review of the current status and future direction of this important field. Part one reviews bone grafting for implantology and reconstructive preprosthetic surgery. Chapters in part two discuss reconstruction and rehabilitation whilst the final group of chapters analyse tissue engineering applications.

CONTENTSBone tissue engineering. Part 1 Bone reconstruction in implantology and reconstructive preprosthetic surgery: Fundamentals of bone grafting in implantology; Cranial bone grafting in maxillary preprosthetic surgery; Maxillary sinus grafting for implant insertion; Symphyseal and alveolar reconstruction in preprosthetic surgery; Mandible corpus reconstruction for implant insertion: The available techniques; Alveolar bi-directional distraction in preprosthetic surgery; Alveolar widening using distraction osteogenesis (DO) in maxillofacial surgery; Bone grafting and Le fort 1 osteotomy in cases of major atrophy of the maxilla. Part 2 Reconstruction in particular situations: Applications of biomaterials in alveolar and maxillofacial bone reconstruction; Implants in congenital missing teeth; Maxillo-mandibular amputations and implants rehabilitation; Alveolar reconstruction in cleft for implant rehabilitation; Bone reconstruction in irradiated situations; Periodontal surgery related to alveolar bone reconstruction for implant insertion. Part 3 Tissue engineering: Mucosal and gingival tissue engineering; Osteoinductivization of dental implants and bone-defect-filling materials; Tissue engineering and endodontics; Tooth regeneration: Current status.



MATERIALS

Characterization of biomaterialsEdited by M Jaffe, New Jersey Institute of Technology, W Hammond, P Tolias, University of Medicine and Dentistry New Jersey and T Arinzeh, New Jersey Institute of Technology, USA


Biomaterials and medical devices must be rigorously tested in the laboratory before they can be implanted in test subjects. Furthermore, by testing devices and materials quickly and efficiently in the laboratory, it is possible to increase the number of materials which may be studied and produce working implants faster. Characterization of biomaterials discusses the latest methods of characterizing materials in order to define the properties and pitfalls of potential biomaterials. Part one discusses the physical and chemical characterization of biomaterials. Part two reviews in-vitro characterization of biomaterial behaviour, whilst the final section assesses the effects of biomaterials on living cells.

CONTENTSPart 1 Physical and chemical characterization of biomaterials: Understanding the phase characteristics of biomaterials; Microscopy techniques for analyzing the phase nature and morphology of biomaterials; Molecular imaging techniques for analyzing the phase orientation of biomaterials; Techniques for analyzing biomaterial chemistry. Part 2 In vitro characterization of biomaterial behaviour: Quantitative assays for measuring cell adhesion and motility in biomaterials; Assays for determining cell differentiation in biomaterials; Bioreactors for evaluating cell infiltration and tissue formation in biomaterials; Techniques for analyzing protein adsorption in biomaterials. Part 3 Assessing the effects of biomaterials on living cells: Evaluating the biocompatibility of biomaterials; Assessing the mutagenic effects of biomaterials: Analyzing the cellular genome and abnormalities; Using microarrays to measure cellular changes induced by biomaterials; Assessing changes in gene expression in cells induced by biomaterials.



Biomaterials

NEW

NEW


Biomimetic biomaterialsStructure and applicationsEdited by A Ruys, University of Sydney, Australia


Researchers and materials scientists are turning to biomimetics as a way to meet the needs for biocompatible, long-lasting materials. Biomimetic biomaterials are synthetic materials which are designed to emulate the natural phenomena from the animal and plant kingdoms. Recent research has revealed that this novel approach can be applied to applications such as soft and hard tissue engineering, adhesives and coatings. This book will provide readers with a thorough overview of the structure and applications of these novel materials. The first set of chapters discuss the structure and surfaces of biomimetic materials whilst the second set of chapters review the biomedical applications.

CONTENTSPart 1 Structure and surfaces of biomimetic biomaterials: Hierarchical structure, mechanical properties and fabrication of biomimetic biomaterials; Biomimetic coatings for biomaterial surfaces; Biomimetic biomaterial adhesives and interfaces. Part 2 Applications of biomimetic biomaterials; Biomimetic materials in regenerative medicine; Biomimetic scaffolds for stem cell tissue engineering; Biomimetic modification of injectable hydrogel collagen matrix proteins for tissue repair; Structure, preparation and applications of biomimetic hydrogels for tissue engineering scaffolds; Biomimetic potential of chitin-based composites for biomedical applications.



Biomedical compositesEdited by L Ambrosio, National Research Council, Italy


CONTENTSPart 1 Introduction to biocomposites. Part 2 Particular applications of biocomposites. Part 3 Biocompatibility, mechanical behaviour and failure of biocomposites. Part 4 The future for biocomposites.



Diamond based materials for biomedical applicationsEdited by R Narayan, University of North Carolina, USA


Carbon has many uses within biomaterials and it exhibits many desirable properties; it is light weight, strong, conductive and can mimic natural materials within the body. Consequently a great deal of research and funding is being put into this interesting material with a view to increasing the variety of medical applications for which it is suitable. The first set of chapters discuss the fundamentals and properties of carbon whilst a final group of chapters discuss novel applications of the material.

CONTENTSPart 1 Introduction to diamond based materials for medical applications: Introduction to medical applications of diamonds and surfaces; Functionalisation of diamond surfaces for medical applications; Biotribology and biological behaviour of nanocrystalline diamond (NCD) coatings for medical applications; Blood compatibility of diamond-like carbon coatings for medical applications. Part 2 Biomedical applications of diamond based materials: Nanostructured diamond coatings for orthopaedic applications; Ultrananocrystalline diamond (UNCD) films for ophthalmological applications; Ultrananocrystalline diamond (UNCD) for neural applications; Nano-diamonds for drug delivery systems; Diamond-based materials for microfluidic devices.



Shape memory alloys for biomedical applicationsEdited by T Yoneyama, Nihon University and S Miyazaki, University of Tsukuba, Japan

Woodhead Publishing Series in Biomaterials No. 15CONTENTSPart 1 Materials: The shape memory effect and superelasticity in Ti-Ni alloys; Mechanical properties of shape memory alloys; Thermodynamics of the shape memory effect in Ti-Ni alloys; Alternative shape memory alloys; Fabrication of shape memory alloy parts; Response of Ti-Ni alloys for dental biomaterials to conditions in the mouth; Understanding, predicting and preventing failure of Ti-Ni shape memory alloys used in medical implants; Surface modification of Ti-Ni alloys for biomedical applications; Biocompatibility of Nitinol for biomedical applications. Part 2 Medical and dental devices: Self-expanding Nitinol stents for the treatment of vascular disease; Orthodontic devices using Ti-Ni shape memory alloys; Endodontic instruments for root canal treatment using Ti-Ni shape memory alloys; Regulation orthopaedic, dental, endovascular and other applications of Ti-Ni shape memory alloys.



Wear of orthopaedic implants and artificial jointsEdited by S Affatato, Istituto Ortopedico Rizzoli di Bologna, Italy


This important book reviews the causes and prevention of implant wear. Part one discusses fundamental issues such as tissue response to wear, the anatomy and biomechanics of hips and knees as well as the materials and design issues they raise for hip, knee and other types of orthopaedic implant. Part two considers wear phenomena in a range of materials, including ultra-high molecular weight (UHMWPE), metal and ceramic joints. It also covers surgical and other factors influencing wear as well as ways of detecting, analysing and predicting implant wear and failure.

CONTENTSPart 1 Fundamentals of implant wear: Introduction to wear phenomenon of orthopaedic implants; Biology of implant wear; Biomechanics of the hip and knee: implant wear; Anatomy of the hip and suitable prostheses; Anatomy of the knee and suitable prostheses; Orthopaedic implant materials and design; Materials used for hip and knee implants. Part 2 Wear phenomenon: The wear phenomenon of Ultra-High Molecular Weight Polyethylene (UHMWPE) joints; The wear phenomenon of metal joints; Wear phenomenon of ceramic joints; The influence of surgical techniques on implant wear; Factors contributing to orthopaedic implant wear; Diagnosis and surveillance of orthopaedic implants; Failure analysis of orthopaedic implants; Wear prediction of orthopaedic implants.



Bioceramics and their clinical applicationsEdited by T Kokubo, Chubu University, Japan

Woodhead Publishing Series in Biomaterials No. 9CONTENTSPart 1 Fundamentals of bioceramics: The structure and mechanical properties of bone; Fabrication processes for bioceramics; The microstructure of bioceramics and its analysis; The mechanical properties of bioceramics; The design of ceramics for joint replacement; Cellular response to bioactive ceramics; In vitro evaluation of bone bioactivity; Osteoconduction and its evaluation; Osteoinduction and its evaluation. Part 2 Types of bioceramics: Alumina ceramics; Zirconia ceramics; Bioactive glasses; Bioactive glass-ceramics; Calcium sulphate; Tricalcium phosphate-based ceramics; Hydroxyapatite; Tricalcium phosphate/hydroxyapatite biphasic ceramics; Si-substituted hydroxyapatite; Calcium phosphate cement; Calcium phosphate coatings; Titania-based materials; Ceramic-polymer composites; Dental ceramics; Dental glass-ceramics. Part 3 Clinical applications of bioceramics: Clinical application of bioactive glasses; Clinical application of bioactive glass-ceramics; Clinical application of hydroxyapatite; Clinical applications of alumina ceramics in joint replacement; Clinical applications of ceramics/polyethylene in joint replacement; Tissue engineering using bioceramics.



Biomaterials

NEW NEW NEW


Coatings for biomedical applicationsEdited by M Driver, Vertellus, UK


The biomaterials sector is rapidly expanding due to the increase in healthcare spending worldwide. Coatings and surface modification of biomaterials provides a means to improve the wear of joints, change the biological interaction between implant and host and combine the properties of various materials to improve device performance. The considerable interest in coatings for biomedical applications has resulted in a great deal of research in industry and academia. This book provides a comprehensive review of coatings and surface modification for biomedical applications, including background, theory, materials and applications. The clear structure and concise review of research provides a valuable resource to researchers in the field of biomedical coatings.

CONTENTSPart 1 Coating types and applications: Hydrophilic coatings for biomedical applications in and ex vivo; Mineral coatings for orthopaedic applications; Other commonly-used biomedical coatings: Pyrolytic carbon coatings; Electrochemical surface modifications of titanium and titanium alloys for biomedical applications; Surface preparation techniques for biomedical applications; Characterization of biomedical coatings. Part 2 Case studies: Coatings for cardiovascular devices: Coronary stents; Coatings for cardiovascular devices: Extracorporeal circuits; Surface coatings for ventricular assist devices; Orthopaedic coatings; Surface coatings in urology; Ophthalmic coatings.



HyaluronanProceedings of an international meeting, September 2000, North East Wales Institute, UKEdited by J F Kennedy, University of Birmingham, G O Phillips, Phillips Hydrocolloid Research Ltd, P A Williams, North East Wales Institute of Higher Education, UK and Guest editor V C Hascall, Lerner Research Institute, USA2 volumes (vol 1: 600 pages, vol 2: 552 pages) 244 x 172mm (6 1/2 x 9 1/2) hardback 2002ISBN: 978 1 85573 570 5 E-ISBN: 978 1 84569 312 1


Bioactive glassesMaterials, properties and applicationsEdited by H O Ylänen, Tampere University of Technology, Finland


Due to their biocompatibility and bioactivity, bioactive glasses are used extensively as implant materials throughout the human body to replace or repair damaged tissue. Once in vivo, this man-made material gradually transforms to mimic natural bone. Consequently, this material has been used extensively since its invention in the 60s and is widely researched throughout the world. Bioactive glasses provides the reader with a comprehensive review of the current status of this unique material and its applications, technologies and future trends. The first part of the book discusses materials and mechanical properties with chapters on spun bioactive glasses, cell interaction and regulatory issues. Part two reviews a wide range of applications in fields such as tissue engineering, orthopaedics and wound healing.

CONTENTSPart 1 Materials and mechanical properties of bioactive glass: Melt-derived bioactive glasses; Surface modification of bioactive glasses; Cell interaction with bioactive glasses and ceramics; Regulatory aspects of bioactive glass. Part 2 Applications of bioactive glass: Bioactive glass and glass ceramic scaffolds for bone tissue engineering; Nanoscaled bioactive glass particles and nanofibres; Bioactive glasses containing composites for bone and musculoskeletal tissue engineering scaffolds; Use of bioactive glasses as bone substitutes in orthopaedics and traumatology; Bioactive glass S53P4 as a bone graft substitute in the treatment of osteomyelitis; Bioactive glass for maxillofacial and dental repair; Bioactive glass and biodegradable polymer composites; Bioactive glasses for wound healing.



Bioactive materials in medicineDesign and applicationsEdited by X Zhao, China Research Academy of Bioactive Molecules and Materials (RABMM) and University of Strathclyde, UK, J M Courtney, University of Strathclyde, UK and H Qian, Queen Mary University London, UK


Bioactive materials in medicine provides readers with information on the current status and developments in bioactive materials for medical applications. Initial chapters focus on the fundamentals of bioactive materials with chapters on such topics as nanotechnology and tissue engineering. Further chapters discuss laboratory design techniques with a view to clinical applications. The final chapters review current biomedical applications such as drug delivery, gene therapy, plastic surgery and the future direction of this increasingly important field.

CONTENTSIntroduction to bioactive materials in medicine. Part 1 Designing bioactive materials for use in medicine: Molecular design of bioactive materials with controlled bioactivity; Bioactive materials and nanotechnology; Bioactive materials and tissue engineering. Part 2 Applications of bioactive materials in medicine: Antibacterial bioactive materials; Bioactive materials in orthopaedics; Bioactive materials in the circulatory system; Bioactive materials in gene therapy; Bioactive materials in plastic surgery and body reconstruction; Bioactive materials in drug delivery systems.



Natural-based polymers for biomedical applicationsPrincipal editor: R L Reis, Section editors: N M Neves, J F Mano, M E Gomes, A P Marques and H S Azevedo, University of Minho, Portugal

Woodhead Publishing Series in Biomaterials No. 12CONTENTSPart 1 Sources, properties, modification and processing of natural-based polymers. Part 2 Surface modification and biomimetic coatings. Part 3 Biodegradable scaffolds and hydrogels for tissue regeneration. Part 4 Naturally-derived hydrogels in tissue engineering and regenerative medicine. Part 5 Systems for the sustained release of molecules. Part 6 Biocompatibility of natural-based polymers.



Biomaterials

NEW


Biomedical hydrogelsBiochemistry, manufacture and medical applicationsEdited by S Rimmer, University of Sheffield, UK


Hydrogels are a type of polymer which, through a range of chemistries, can be manipulated to alter and control the hydrogel’s interactions with cells and tissues. Due to their significant water content, hydrogels possess a degree of flexibility similar to natural tissue. This book explores the diverse range and use of hydrogels, focusing on processing methods and novel applications. Chapters in part one review methods of synthesising hydrogels, including chapters on hydrogel swelling and controlling the structure and properties of hydrogels. The final group of chapters analyse applications such as spinal implants and ophthalmic prostheses.

CONTENTSPart 1 Processing of hydrogels: Hydrogel swelling behaviour and its biomedical applications; Superabsorbent cellulose-based hydrogels for biomedical applications; Synthesis of hydrogels – control of structure and properties; Processing and fabrication technologies for biomedical hydrogels; Regulation of novel biomedical hydrogel products; Failure of hydrogel implants – mechanical properties. Part 2 Applications: Spinal disc implants using hydrogels; Hydrogels for intraocular lenses and other ophthalmic prostheses; Cartilage replacement implants using hydrogels; Imaging implants in situ.



Biomedical polymersEdited by M Jenkins, University of Birmingham, UK


‘...this publication offers an unsurpassable opportunity to facilitate immersion in a rapidly expanding interdisciplinary area.’

‘...a source of reference for scientists and, in general, all professionals involved in the development and use of this important group of biomaterials.’

Revista de Plásticos Modernos

CONTENTSIntroduction to polymeric scaffolds for tissue engineering; Introduction to polymeric drug delivery systems; Hydrogels in cell encapsulation and tissue engineering; Biodegradable polymers for drug delivery systems; Polymers as replacement materials for heart valves and arteries; Ultra-High Molecular Weight Polyethylene (UHMWPE) in joint replacement; Polymers in biosensors; Tissue engineering using natural polymers.



Injectable biomaterialsScience and applicationsEdited by B Vernon, Arizona State University, USA


The development of novel injectable biomaterials to be used in non-invasive surgical procedures has attracted much attention in recent years. Their easy deliverability into the body is the critical advantage, since it allows their deployment to the implantation site using minimally invasive surgical techniques. Injectable biomaterials provides comprehensive coverage of this important technology. Part one discusses materials and mechanical properties of injectable biomaterials. Chapters in part two cover clinical applications such as drug delivery and a final group of chapters analyse technologies and developments.

CONTENTSPart 1 Materials and properties: Designing clinically useful substitutes for the extracellular matrix; Designing ceramics for injectable bone graft substitutes; Rheological properties of injectable biomaterials; Improving mechanical properties of injectable polymers and composites. Part 2 Clinical applications: Drug delivery applications of injectable biomaterials; Tissue engineering applications of injectable biomaterials; Vascular applications of injectable biomaterials; Orthopaedic applications of injectable biomaterials; Dental applications of injectable biomaterials; Injectable polymeric carriers for gene delivery systems. Part 3 Technologies and developments: Environmentally responsive injectable materials; Injectable nanotechnology; Injectable biodegradable materials; Troubleshooting and hurdles to development of biomaterials; Biocompatibility of injectable materials; Future applications of injectable biomaterials: The use of microgels as modular injectable scaffolds.



Metals for biomedical devicesEdited by M Niinomi, Tohoku University, Japan

Woodhead Publishing Series in Biomaterials No. 25CONTENTSPart 1 General introduction: Overview of metals and biomedical applications; Metal selection for biomedical devices. Part 2 Mechanical behaviour, degradation and testing of metals for biomedical devices: Mechanical properties of metallic biomaterials; Corrosion of metallic biomaterials; Fatigue and failure of metallic biomaterials; Mechanical testing of metallic biomaterials; Wear testing of metallic biomaterials; Biocompatibility of metallic biomaterials. Part 3 Processing metals for biomedical applications: Forging metals and alloys for biomedical applications; Surface treatment of metallic biomaterials; Coatings for metallic biomaterials; Biocompatible polymer assembly on metal surfaces; Sterilisation and cleaning of metallic biomaterials. Part 4 Specific applications of metals for biomedical devices: Orthopaedic applications of metallic biomaterials; New generation metallic biomaterials; Degradable metallic biomaterials for cardiovascular applications.



MEDICAL TEXTILES

Biotextiles as medical implantsEdited by M W King, B S Gupta, North Carolina State University, USA and R Guidoin, Laval University Quebec, Canada

Woodhead Publishing Series in Textiles No. 113

This book provides an invaluable single source of information on the main types of textile materials and products used for medical implants. The first series of chapters provide the reader with an overview of biotextile structures, the types of textiles used for medical implants and processing issues. The second group of chapters focus on the different types of biotextile implants, including sutures and cardiovascular implants.

CONTENTSPart 1 Technologies: Biotextile fibres, yarn and fabric production; Nanofibers for biotextile applications; Surface modification of textiles; Sterilisation techniques for biotextiles; Regulation of biotextiles for medical use; Assessing the effectiveness of biotextiles as medical implants. Part 2 Applications: Drug delivery systems using biotextiles; Surgival sutures; Embolic protection devices; Septal defect repair; Anterior cruciate ligament prostheses; Percutaneous heart valves; Cartilage; Neural tissues.

Published in association with The Textile Institute



Smart textiles for medicine and healthcareMaterials, systems and applicationsEdited by L Van Langenhove, University of Ghent, Belgium

Woodhead Publishing Series in Textiles No. 63Published in association with The Textile Institute



Medical textiles and biomaterials for healthcareEdited by S C Anand, University of Bolton, J F Kennedy, Chembiotech Ltd, UK, M Miraftab and S Rajendran, University of Bolton

Woodhead Publishing Series in Textiles No. 48CONTENTSBasic biomaterials; Healthcare and hygiene products; Infection control and barrier materials; Bandaging and pressure garments; Woundcare materials; Implantable devices; Medical devices; Smart technologies.



Biomaterials

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Textiles for hygiene and infection controlEdited by B J McCarthy, TechniTex Faraday Limited, UK


With issues such as a rising population and increasing concerns surrounding the environment and infection prevention, the need to understand and improve hygiene and healthcare products has become increasingly important. This book begins with an insight into the types of fibres used and explores how hygiene and infection control textiles are designed and produced. Concluding chapters discuss a range of applications.

CONTENTSPart 1 Design and production techniques for hygiene textiles: The design of novel hygiene textile products; Nanotechnology and its applications in medical hygiene textiles; Use of knitted spacer fabrics for hygiene applications; Innovative and sustainable packaging strategies for hygiene products; Biodegradable hygiene products. Part 2 Design and production techniques for infection-control textiles: Micro-organisms, infection and the role of textiles; Creating barrier textiles through plasma processing; Disposable and reusable medical textiles; Ensuring fabrics survive sterilisation. Part 3 Product types: Washable textile-based absorbent products for incontinence; Biological containment suits used in microbiological high containment facilities and by emergency responders; Coated textiles for skin infections; Antimicrobial treatments of textiles for hygiene and infection control applications: an industrial perspective.




Advanced textiles for wound careEdited by S Rajendran, University of Bolton, UK


‘…a detailed and thorough look into this exciting application of textiles.’International Textile and Apparel Association

CONTENTSPart 1 The use of textiles in particular aspects of wound care: Wound management and dressings; Testing dressings and wound management materials; Textile materials and structures for wound care products; Interactive dressings and their role in moist wound management; Bioactive dressings to promote wound healing; Advanced textiles for wound compression; Antimicrobial textiles dressings in managing wound infection; Novel textiles in managing burns and other chronic wounds. Part 2 Types of advanced textile for wound care: Drug delivery dressings; The use of ‘smart’ textiles for wound care; Composite dressings for wound care; Textile-based scaffolds for tissue engineering.




Handbook of medical textilesEdited by V Bartels, Bartels Scientific Consulting GmbH, Germany


This invaluable reference provides a broad overview of the different types of medical textiles, as well as focusing on specialised topics. Part one discusses the types and properties of medical textiles from reusable textiles to fabrics with cosmetic effects. Part two focuses on how textiles interact with skin. Part three provides the latest developments in textiles for hygiene and infection control and part four concludes by providing a range of applications and case studies.

CONTENTSPart 1 Types and properties of medical textiles: Modern textiles and biomaterials for healthcare; Hi-tech textiles for interactive wound therapies; Reusable medical textiles; Nonwoven materials and technologies for medical applications; Textiles for implants and regenerative medicine; Textiles with cosmetic effects; Drug-releasing textiles; Medical textiles and thermal comfort. Part 2 Textiles and the skin: Contact sensations of medical textiles on the skin; Mechanical skin irritations due to textiles; Allergies caused by textiles; Biofunctional textiles based on cellulose and their approaches for therapy and prevention of atopic eczema. Part 3 Textiles for hygiene: Infection prevention and control and the role of medical textiles; Absorbent products for personal health care and hygiene; Bio-functional textiles; Hospital laundries and their role in medical textiles; Odour control of medical textiles. Part 4 Medical textile case studies and applications: Textiles for medical filters; Textiles for patient heat preservation during operations; Evaluation of occupational clothing for surgeons: achieving comfort and avoiding physiological stress through suitable gowns; Superabsorbents and their medical applications; Nanofibrous textiles in medical applications.




Medical and healthcare textilesEdited by S C Anand, University of Bolton, J F Kennedy, Chembiotech Ltd, M Miraftab and S Rajendran, University of Bolton, UK

Woodhead Publishing Series in Textiles No. 75CONTENTSPart 1 Infection control and barrier materials. Part 2 Healthcare and hygiene products. Part 3 Wound care materials. Part 4 Bandaging and pressure garments. Part 5 Implantable materials. Part 6 Medical devices. Part 7 Smart materials and technologies. Part 8 Industry standards and regulations.




TECHNOLOGIES AND PERFORMANCE

Microfluidics for biomedical applicationsEdited by X-J J Li, University of Texas and Y Zhou, Genus Plc, USA


Microfluidic devices are used to manipulate fluid such as blood, cell suspensions and therapies. This important technology is suitable for numerous applications from drug delivery to tissue engineering. The use of microfluidics in medicine is still evolving. As microfluidic devices can be cheaply made and are small, applications are continually being researched and produced in the medical field. This important book discusses the fundamentals of microfluidics and will provide information on a wide range of medical applications. The first set of chapters discuss the fundamentals of microfluidic devices for medical applications. Subsequent chapters look at drug delivery applications, applications in cell biology, tissue engineering and diagnostics. In the final set of chapters, sensing applications are then reviewed.

CONTENTSPart 1 Fundamentals of microfluidic technologies: Glass and polymer (PC, PMMA, COC/COP) fabrication techniques for microfluidic medical devices; Digital microfluidics technologies for biomedical devices; Nanoimprint lithography for microfluidic medical devices; Components for fluid delivery, transport and control for microfluidic medical devices; Actuation mechanisms for microfluidic medical devices; Medical micro-device surface coatings. Part 2 Microfluidics for drug delivery and discovery applications: Controlled release of drugs and therapeutic proteins using microfluidic devices; Microneedles for drug delivery applications. Part 3 Microfluidics for cell manipulation and analysis: Microfluidics for cell manipulation; Microfluidics for single-cell analysis; Automated micro-robotic cell injection. Part 4 Microfluidics for tissue engineering applications: Microfluidics for developing tissue scaffolds; Organs on a chip - microfluidic devices for analyzing and supporting gut function; Microfluidic devices for analysing and culturing stem cells; Smart bioMEMS implants for medical applications. Part 5 Microfluidics for diagnostic applications: Microfluidics for monitoring pancreatic islets in the detection of diabetes; Microfluidic immunoassays for protein analysis; Point-of-care microdevices for glucose and lithium measurement; Low-cost microfluidic diagnosis of glucose and protein; Microfluidics for genetic analysis. Part 6 Microfluidics for biomedical sensing and imaging: Optical and electrochemical microfluidic biosensors using nanostructured materials; Micro-reactor: Microfluidic chips for the systhesis of positron emission tomography in clinical diagnosis.



Biomaterials

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Biomedical imagingApplications and advancesEdited by P Morris, University of Nottingham, UK


The development of imaging techniques is of great importance for the monitoring of medical implants, diagnosis of disease and for strategies for personalised medicine. Significant advances are being made in this technology and this book will discuss the latest advances and developments in this increasingly important field. The book begins with an introduction to the field and its various technologies. Following on from this, chapters provide readers with a wide ranging review of medical applications such as brain, ophthalmic, musculoskeletal and whole body imaging. This text will be invaluable to those concerned with imaging and diagnosis.

CONTENTSPET imaging; Intravascular MR; Atomic force microscopy; Role of quantitative image biomarkers for the assessment of therapy response in brain tumor; Ophthalmic imaging; Methods for detecting ischaemic heart disease; Musculoskeletal imaging; Whole body imaging; Intravascular MR.



Medical modellingThe application of advanced design and development techniques in medicineR Bibb, University of Wales, UK


Medical modelling is an increasingly important tool in surgery and rehabilitative medicine. This authoritative book describes the key steps in modelling from acquisition of medical scan data, transfer and translation of data formats, methods of utilising the data and finally using the information to produce physical models using rapid prototyping techniques. Technologies are fully described, highlighting their key characteristics, advantages and disadvantages. A series of case studies illustrates a broad range of medical applications in surgery or prosthetic rehabilitation. The book is a valuable reference for a wide range of professionals involved in such areas as orthopaedics, orthodontics, and prosthetics.

CONTENTSBasic human anatomy; Computed tomography scanning; Magnetic resonance scanning; Non contact surface scanning; Export data format and media; Using medical scan data; Physical reproduction; Case studies; Future developments, Bibliography.



Bio-tribocorrosion in biomaterials and medical implantsEdited by Y Yan, University of Science and Technology Beijing, China


Due to the increase in implanted biomaterials, issues relating to their long-term durability need to be addressed. The science of bio-tribocorrosion is concerned with implant surface changes resulting from interactions such as loading and various chemical reactions which occur within the bodily environment. Bio-tribocorrosion in biomaterials and medical implants discusses the processes of bio-tribocorrosion and will help readers achieve safer and more durable implants. Chapters in the first section of the book will discuss the fundamentals of bio-tribocorrosion. The next set of chapters cover wear-corrosion mechanisms whilst the following group of chapters review the biological environment. The final group of chapters discuss bio-tribocorrosion in the clinical environment.

CONTENTSPart 1 Fundamentals of bio-tribocorrosion: Introduction to bio-tribocorrosion; Topography in bio-tribocorrosion; Coatings for Total Joint Replacement (TJR); Coatings for dental implants. Part 2 Wear-corrosion mechanisms: Synergistic mechanisms of bio-tribocorrosion; Fretting corrosion in biomedical implants; Wear mechanisms in bio-tribocorrosion; Abrasion-corrosion behaviours of implant materials; Loosening of total joint replacement (TJR); Predicting bio-tribocorrosion in wear in dentistry. Part 3 Biological environment: Ion release processes; Growth of passive films; Biofilms in the oral environment; Synovial fluid – the role of protein adsorption on corrosion. Part 4 Bio-tribocorrosion in the clinical environment: Bio-tribocorrosion in dental applications; Bio-tribocorrosion: surface interactions in total joint replacement (TJR); In vitro testing and clinical applications of artificial joints; The application of bio-tribocorrosion testing protocol.



Molecular interfacial phenomena of polymers and biopolymersEdited by P Chen, University of Waterloo, Canada


‘…it will be valued by researchers and postgraduate students with interest in polymers or biopolymers.’

‘All the sections are unique and specialised to the authors’ field of expertise.’

Materials World712 pages 234 x 156mm (6 x 9) hardback 2005ISBN: 978 1 85573 928 4 E-ISBN: 978 1 84569 083 0


Joining and assembly of medical materials and devicesEdited by Y N Zhou, University of Waterloo, Canada and M D Breyen, Medtronic Inc, USA


Medical devices are becoming more intricate with the use of a wide range of materials and components which must be joined effectively and safely. Joining and assembly of medical materials and devices provides a comprehensive analysis of the practical techniques that can be used to join and assemble medical materials. The first set of chapters review the fundamentals of joining medical materials. A second group of chapters discuss processes for joining medical metals whilst the next set of chapters provide a review of processes for joining medical plastics. The final group of chapters provide readers with an overview of joining biomaterials and tissue implants.

CONTENTSPart 1 Fundamentals of joining and assembly in medical materials and devices: Introduction to medical materials and devices; Introduction to joining methods in medical applications; Microwelding methods in medical components and devices; The effects of sterilization on medical materials and welded devices. Part 2 Joining and assembly of medical metals: Overview of ultrasonic welding of metals for medical applications; Microwelding of shape memory alloys; Bonding of platinum (pt) alloys and stainless steel wires for electronic medical devices; Evaluating the corrosion performance of metal medical device welds; Laser hermetic welding of metallic implantable medical devices; Validating hermeticity in welded metallic implantable medical devices. Part 3 Joining and assembly of medical plastics: Overview of Welding methods for medical plastics; Ultrasonic welding of medical plastics; Radio frequency (RF)/dielectric welding of medical plastics; Transmission laser welding strategies for medical plastics; Bonding strategies and adhesives for joining medical polymers. Part 4 Joining and assembly of biomaterial and tissue implants: Advanced metal-ceramic joining techniques for orthopaedic applications; Tissue adhesives and sealants for surgical applications; Antibacterial adhesives for bone and tooth repair; Testing bond strength: The case of dental biomaterials.



Surfaces and interfaces for biomaterialsEdited by P Vadgama, Queen Mary University of London, UK

Woodhead Publishing Series in Biomaterials No. 2824 pages 234 x 156mm (6 x 9) hardback 2005ISBN: 978 1 85573 930 7 E-ISBN: 978 1 84569 080 9


Biomaterials

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Lasers for medical applicationsDiagnostics, therapy and surgeryEdited by H Jelinkova, Czech Technical University, Czech Republic

Woodhead Publishing Series in Electronic and Optical Materials No. 37

The laser has become an indispensable medical tool and new techniques and treatments are being pioneered all the time. This book begins by looking at the response of tissue to laser light. It then outlines the types of laser used in medicine, including solid-state, gas, dye and semiconductor lasers. Next the use of lasers for diagnostics is considered, including optical coherence tomography, laser spectroscopy in biomedicine and optical biopsy. A large number of chapters are dedicated to applications of lasers in therapy and surgery. Medical fields such as dermatology, urology, gynaecology, ophthalmology, dentistry and neurology are covered. The book ends with a look at medical laser safety.

CONTENTSIntroduction: The history of lasers in medicine. Part 1 Laser-tissue interaction: Laser characteristics; The response of tissue to laser light; Optical fibers for medical applications. Part 2 Types of laser used in medicine: Solid state lasers for medical applications; Gas lasers for medical applications; Liquid and solid-state tunable organic dye lasers for medical applications; Semiconductor lasers for medical applications. Part 3 Lasers in diagnostics: Optical sources for optical coherence tomography; Laser spectroscopy in medical diagnostics; Time-resolved fluorescence polarization spectroscopy and optical imaging of smart receptor-targeted contrast agents in tissues for cancer detection. Part 4 Laser therapy and surgery; Laser therapy in ophthalmology; Lasers in dermatology; Lasers in cardiology; Lasers in gynecology; Lasers in otorhinolaryngology (ORL) and head and neck surgery; Lasers in neurology; Lasers in dentistry; Laser in orthopaedic surgery; Photodynamic therapy (PDT) for cancer treatment; Cancer laser therapy using gold nanoparticles; Laser safety: Regulations, standards, and guidelines for practice.



Cellular response to biomaterialsEdited by L Di Silvio, King’s College London, UK

Woodhead Publishing Series in Biomaterials No. 16CONTENTSPart 1 Cell responses to biomaterials using polymers and ceramics. Part 2 Cell responses and regenerative medicine. Part 3 The effect of surfaces and proteins on cell response.



Non-metallic biomaterials for tooth repair and replacementEdited by P Vallittu, University of Turku, Finland


This important book focuses on biomaterials for tooth repair and, in particular, dental restorations. The first part of the book covers dental glasses and looks at the natural structure of teeth. Part two discusses a wide range of dental polymer composites whilst the final set of chapters in part three look at dental ceramics.

CONTENTSPart 1 Structure, modification and repair of dental tissues: Structure and properties of enamel and dentin; Biomineralization and biomimicry of tooth enamel; Enamel and dentin bonding for adhesive dental restorations; Enamel matrix proteins (EMPs) for periodontal regeneration. Part 2 Dental ceramics and glasses for tooth repair and replacement: Processing and bonding of dental ceramics; Wear properties of dental ceramics; Sol-gel derived bioactive glass ceramics for dental applications. Part 3 Dental composites for tooth repair and replacement: Composite adhesive restorative materials for dental applications; Antibacterial composite restorative materials for dental applications; Effects of particulate filler systems on the properties and performance of dental polymer composites; Composite based oral implants; Fibre reinforced composites (FRCs) as dental materials; Luting cements for dental applications.



Medical roboticsMinimally invasive surgeryEdited by P Gomes, Cambridge Consultants, UK


Beginning with an introduction to robot-assisted minimally invasive surgery (MIS), the core technologies of the field are discussed. Key current and future applications for robotics in a range of surgical procedures and medical applications are then explored, before the book concludes with a discussion of ethical issues related to the use of medical robotics.

CONTENTSIntroduction to robot-assisted Minimally Invasive Surgery (MIS); Localisation and tracking technologies for medical robotics; Robotics for neurosurgery; Robotic systems for cardiovascular interventions; Robotics in orthopaedic surgery; Robotic-assisted knee replacement surgery; Robotics in Ear, Nose and Throat (ENT) surgery; Robotic-assisted eye surgery; Robotics for Minimally Invasive Surgery (MIS) and Natural Orifice Transluminal Endoscopic Surgery (NOTES); Meso-Scale mobile robots for gastrointestinal Minimally Invasive Surgery (MIS); Real-time software platform using MRI for in vivo navigation of magnetic micro-robots; Robotic surgery and ethical issues.



Implantable sensor systems for medical applicationsEdited by A Inmann, Andreas Inmann Consulting, USA and D Hodgins, European Technology for Business Limited, UK


This book discusses the core technologies needed for implantable sensor systems and their current and potential medical applications. Chapters in part one review a wide range of core technologies which are fundamental to implantable medical sensor systems. Part two reviews considerations and challenges for implantable medical sensor systems whilst the final part discusses the various applications areas of implantable sensor systems.

CONTENTSPart 1 Fundamentals on implantable sensor systems: Materials for implantable systems; Material-tissue interfaces in implantable systems; Packaging and coating materials for implantable systems; Microassembly and micropackaging of implantable systems; Electrode array design and fabrication for implantable systems; Biofuel cells as sustainable power sources for implantable systems. Part 2 Challenges of implantable systems: Biocompatibility of implantable systems; Sterilisation considerations for implantable sensor systems; Protection of data confidentiality and patient privacy in medical sensor networks; Developing active implantable medical devices in a regulated environment. Part 3 Applications of implantable systems: Microelectromechanical systems (MEMS) for in-vivo applications; Tripolar interfaces for neural recording; Sensors for motor neuroprostheses; Implantable wireless body area networks; Retina implants.



Biosensors for medical applicationsEdited by S Higson, Cranfield University, UK


Biosensors for medical applications provides a comprehensive review of established, cutting edge and future trends in biomedical sensors and their applications.

CONTENTSPart 1 Principles and transduction approaches: Electrochemical biosensors for medical applications; Piezoelectric biosensors for medical applications; Nano-sized biosensors for medical applications; Impedence interrogated affinity biosensors for medical applications: Novel targets and mechanistic studies; Protocols for enzyme biosensors. Part 2 Applications of medical biosensors: Biosensors for DNA and RNA detection and characterization; Biosensors for disease biomarker detection; Affibodies as an alternative to antibodies in biosensors for cancer markers; Biosensors for drug testing and discovery; Biosensors for non-invasive measurements; Wearable biosensors for medical applications.



Biomaterials

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MEMS for biomedical applicationsEdited by S Bhansali and A Vasudev, Florida International University, USA


The application of Micro Electro Mechanical Systems (MEMS) in the biomedical field is leading to a new generation of medical devices. MEMS for biomedical applications reviews the wealth of recent research on fabrication technologies and applications of this exciting technology. Part one introduces the fundamentals of MEMS for biomedical applications, exploring the microfabrication of polymers and reviewing sensor and actuator mechanisms. Part two goes on to consider MEMS for biomedical sensing and diagnostic applications. MEMS for tissue engineering and clinical applications are the focus of part three. Finally, part four reviews emerging biomedical applications of MEMS, from implantable neuroprobes and ocular implants to cellular microinjection.

CONTENTSPart 1 Fundamentals of MEMS for biomedical applications: Microfabrication of polymers for bioMEMS; Review of sensor and actuator mechanisms for bioMEMS. Part 2 MEMS for biomedical sensing and diagnostic applications: MEMS for in vivo sensing; MEMS and electrical impedance spectroscopy (EIS) for non-invasive measurement of cells; MEMS ultrasonic transducers for biomedical applications; Lab-on-chip (LOC) devices and microfluidics for biomedical applications. Part 3 MEMS for tissue engineering and clinical applications: Fabrication of cell culture microdevices for tissue engineering applications; MEMS manufacturing techniques for tissue scaffolding devices; BioMEMS for drug delivery applications; Applications of MEMS technologies for minimally invasive medical procedures; Smart Microgrippers for bioMEMS applications; Microfluidic techniques for the detection, manipulation and isolation of rare cells. Part 4 Emerging biomedical applications of MEMS: MEMS as implantable neuroprobes; MEMS as ocular implants; Cellular microinjection for therapeutics and research applications; Hybrid MEMS: Integrating inorganic structures into live organisms.



Sterilisation of polymer healthcare productsW Rogers326 pages 255 x 190mm (7 1/2 x 10) paperback 2005ISBN: 978 1 85957 490 4£95.00/US$160.00/€115.00www.woodheadpublishing.com/9781859574904 *Not available for distribution in the USA.

Minimized cardiopulmonary bypass techniques and technologiesEdited by T Gourlay, University of Strathclyde, UK and S Gunaydin, K. Kale University, Turkey


‘The book is comprehensive in its scope and authoritative in the experience of its chapter authors. I commend the book to all members of cardiac surgery teams - surgeons, cardiologists, anaesthetists and perfusionists.’

Professor Ken Taylor, Emeritus Professor of Cardiac Surgery, Imperial College and The Hammersmith Hospital, London (from the

Foreword)

Traditional cardiopulmonary bypass (CPB) techniques have suffered from a number of disadvantages including haemodilution, inflammation and post-operative bleeding. Minimised cardiopulmonary bypass techniques use developments in perfusion technology to significantly reduce foreign surface-blood interactions to make bypass simpler and safer. This important book reviews key developments and issues relating to this promising technology. Part one covers the broad range of CPB pathophysiology, including anticoagulant protocols, the impact of CPB circuit surfaces, optimal haemodilution levels, and the important issue of CPB-induced systemic inflammatory response syndrome. Part two focuses on the issues of the new equipment developed for mini-CPB, optimal myocardial protection protocols and CPB perfusate options. Part three discusses clinical issues, including patient selection, coronary and valve surgery protocols and, among others, paediatric patients.

CONTENTSPart 1 Introduction to minimized cardiopulmonary bypass: Historical development of minimized cardiopulmonary bypass; Anticoagulation protocols for minimized cardiopulmonary bypass; Minimized extracorporeal circulation: Physiology and pathophysiology; Blood–surface interface in miniatururised extracorporeal circulation systems; Hemodilution: Physiology and pathophysiology; Inflammatory response and minimized cardiopulmonary bypass. Part 2 Minimized cardiopulmonary bypass equipment: Design and principles of the minimized extracorporeal circuit; Cardiopulmonary bypass perfusate; Myocardial preservation techniques for mini-bypass. Part 3 Clinical applications of minimized cardiopulmonary bypasses: Minimized cardiopulmonary bypass: Objectives and indications; Coronary artery bypass grafting (CABG); Valve surgery using minimized perfusion circuits; Minimising cardiopulmonary bypass in children; Comparison of minimized circulation with off-pump coronary artery bypass grafting (OPCAB) and conventional surgery; Minimally invasive cardiac surgery, port-access and robotic surgery.



Durability and reliability of medical polymersEdited by M Jenkins and A Stamboulis, University of Birmingham, UK


Given the widespread use of polymers in medical devices, the durability and reliability of this material in use is an area of critical importance. Durability and reliability of medical polymers reviews the performance of both bioresorbable and non-bioresorbable medical polymers.

CONTENTSPart 1 Types and properties of bioresorbable medical polymers: Types of bioresorbable polymers for medical applications; The effect of molecular structure on the properties of biomedical polymers; Processing of bioresorbable and other polymers for medical applications; Understanding transport phenomena and degradation of bioresorbable medical polymers; Synthetic bioresorbable polymers; Using synthetic bioresorbable polymers for orthopaedic tissue regeneration. Part 2 Aspects of durability and reliability of non-bioresorbable medical polymers: Wear processes in polymer implants; Ageing processes of biomedical polymers in the body; The failure of synthetic polymeric medical devices; Manufacturing defects in polymeric medical devices.



Biointegration of medical implant materialsScience and designEdited by C P Sharma, Sree Chitra Tirunal Institute for Medical Sciences and Technology, India

Woodhead Publishing Series in Biomaterials No. 26CONTENTSBiointegration: An introduction. Part 1 Soft tissue biointegration: Biocompatibility of engineered soft tissue created by stem cells; Replacement materials for facial reconstruction at the soft tissue-bone interface; Corneal tissue engineering; Tissue engineering for small-diameter vascular graft; Stem cells for organ regeneration. Part 2 Drug delivery: Materials facilitating protein drug delivery and vascularisation; Inorganic nanoparticles for targeted drug delivery; Alginate-based drug delivery devices; Functionalised nanoparticles for targeted drug delivery. Part 3 Design considerations: Biocompatibility of Materials and its relevance to drug delivery and tissue engineering; Mechanisms of failure of medical implants during long-term use; Rapid prototyping in biomedical Engineering: Structural intricacies of biological materials.



Biomaterials

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Biocompatibility and performance of medical devicesEdited by J-P Boutrand, Biomatech, France


Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe, biocompatible and perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices. Part one introduces key concepts and challenges faced in relation to biocompatibility in medical devices. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing for soft and hard tissues implants discussed. Part four provides information on the international regulation of medical devices in the European Union, Japan and China, before concluding in part five with a review of histopathology principles for biocompatibility and performance studies.

CONTENTSPart 1 Introduction to biocompatibility in medical devices: Concepts in biocompatibility; Challenges in biocompatibility and failure of biomaterials; Biological safety evaluation planning of biomaterials; Biomechanical and biochemical compatibility in innovative biomaterials. Part 2 Evaluation and characterisation of biocompatibility in medical devices: Material and chemical characterization for the biological evaluation of medical device biocompatibility; Allowable limits for toxic leachables: Practical Use of ISO 10993-17 Standard; In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices; Blood compatibility assessment in medical devices: Considerations and standards; Evaluating biocompatibility in biomaterials - an industry perspective; Case study - overcoming negative tests results during manufacture; Methods for the characterisation and evaluation of drug-device combination products. Part 3 Testing and interpreting the performance of medical devices: Methods and interpretation of preclinical performance studies for bone implants; Methods and interpretation of preclinical performance studies for dental implants; Methods and interpretation of preclinical performance studies for soft tissues implants; Mechanical testing for soft and hard tissues implants. Part 4 International regulation of medical devices: Biological evaluation and regulation of medical devices in the European Union; Biological evaluation and regulation of medical devices in Japan; Medical device regulations in China. Part 4 Histopathology principles for biocompatibility and performance studies: Microscopic and ultrastructural pathology in medical devices.



Sterilisation of biomaterials and medical devicesEdited by S Lerouge, University of Montréal, Canada and A Simmons, University of New South Wales, Australia


The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes. The book reviews the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices.

CONTENTSIntroduction to sterilisation: Definitions and challenges; Steam and dry heat sterilisation of biomaterials and medical devices; Sterilisation of healthcare products by ionising radiation: Principles and standards; Ethylene Oxide (ETO) sterilisation of healthcare products; Non-traditional sterilisation techniques for biomaterials and medical devices; Sterilisation and decontamination of surfaces by plasma discharges; Sterilisation techniques for polymers; Sterilisation of healthcare products by ionising radiation: Sterilisation of drug-device products and tissue allografts; Antimicrobial coatings for self-sterilisation; Prions and endotoxins: Reprocessing strategies for reusable medical devices; Future trends for the sterilisation of biomaterials and medical devices.



Sterilisation of tissues using ionising radiationsEdited by J F Kennedy, University of Birmingham, G O Phillips, Phillips Hydrocolloid Research Ltd and P A Williams, The North East Wales Institute, UK


‘…a useful tool for tissue bankers, tissue recipients and donors as well as a supplement for transplant surgeons and students of medicine.’

Carbohydrate Polymers352 pages 244 x 172mm (6 1/2 x 9 1/2) hardback 2005ISBN: 978 1 85573 838 6 E-ISBN: 978 1 84569 077 9


Developments in tissue engineered and regenerative medicine productsA practical approachJ Basu and J W Ludlow, Tengion Inc, USA


Developments in tissue engineered and regenerative medicine products summarizes recent developments in tissue engineering and regenerative medicine with an emphasis on commercialization and product development. Preclinical and clinical testing of tissue engineered and regenerative medicine products, regulatory, quality control, manufacturing issues, as well as generating and securing intellectual property and freedom to operate considerations are presented. This book represents a complete ‘how-to’ manual for the development of tissue engineered and regenerative medicine products from conceptualization to clinical trial to manufacturing.

CONTENTSOverview of tissue engineering/regenerative medicine; Cells; Biomaterials for TE/RM products; Neo-Bladder: A foundational technology platform for tubular organ regeneration; Neo-Urinary Conduit™; Tissue engineering of non-bladder tubular organs; Tissue engineering of solid organs; Regulatory and quality control; Pre-clinical and clinical evaluation of TE/RM products; Manufacturing; Intellectual property.



Tissue engineering using ceramics and polymersEdited by A R Boccaccini, Imperial College London and J Gough, University of Manchester, UK

Woodhead Publishing Series in Biomaterials No. 8CONTENTSPart 1 General issues: Ceramic biomaterials; Polymeric biomaterials; Bioactive ceramics and glasses; Biodegradable and bioactive polymer/ceramic composite scaffolds; Transplantation of engineered cells and tissues; Surface modification to tailor the biological response; Combined tissue engineering and drug delivery; Carrier systems and biosensors for biomedical applications; Characterisation using x-ray photoelectron spectroscopy (XPS) and secondary ion spectrometry (SIMS); Characterisation using environmental scanning electron microscopy (ESEM); Characterisation of cells on tissue engineered construsts using imaging techniques/microscopy; Characterisation using Raman micro-spectroscopy. Part 2 Tissue and organ generation: Engineering of tissues and organs; Bone regeneration and repair using tissue engineering; Bone tissue engineering and biomineralisation; Cardiac tissue engineering; Intervertebral disc tissue engineering; Skin tissue engineering; Liver tissue engineering; Kidney tissue engineering; Bladder tissue engineering; Nerve bioengineering; Lung tissue engineering; Intestine tissue engineering; Micromechanics of hydroxyapatite-based biomaterials and tissue engineering scaffolds; Cartilage tissue engineering.



Biomaterials

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Progenitor and stem cell technologies and therapiesEdited by A Atala, Wake Forest Institute of Regenerative Medicine, USA


Progenitor and stem cells have the ability to renew themselves and change into a variety of specialised types, making them ideal materials for therapy and regenerative medicine. Progenitor and stem cell technologies and therapies reviews the range of progenitor and stem cells available and their therapeutic application. Part one reviews basic principles for the culture of stem cells before discussing technologies for particular cell types. Part two discusses wider issues such as intellectual property, regulation and commercialisation of stem cell technologies and therapies. The final part of the book considers the therapeutic use of stem and progenitor cells.

CONTENTSPart 1 Basic principles of stem cells: Basic principles for stem cell culture; Basic principles of human embryonic stem cells; Basic principles in generating induced pluirpotent stem cells; Basic principles of amniotic and placental stem cells; Basic principles of cord blood stem cells; Basic principles of multipotent stem cells. Part 2 Enabling cell therapy: Intellectual property claims to stem cell technologies: Research, clinical testing and product sales; Regulatory considerations of stem and progenitor cell-based products: US Food and Drug Administration; Cell therapy commercialisation; Stem cell tourism. Part 3 Tissue-specific progenitor cells: Adipose tissue-derived stem cell biology and therapy; Umbilical cord blood (UCB) progenitor stem cell biology and therapy; Auditory progenitor stem cell biology and therapy; Olfactory mucosa: neural stem and progenitor cells for nervous system repair and cell models of brain disease; Oral cavity progenitor and stem cell biology and therapy; Bone marrow mesenchymal progenitor and stem cell biology and therapy; Progenitor and stem cell therapies for cartilage repair; Cardiac stem and progenitor cell biology and therapy; Renal progenitor and stem cell biology and therapy; Lung progenitor and stem cell biology and therapy; Genitourinary progenitor and stem cell biology and therapy.



Biomaterials, artificial organs and tissue engineeringEdited by L Hench and J Jones, Imperial College of Science, Technology and Medicine, UK


‘…highly useful for students of biomaterials, material science and medicine.’

‘…provides an overview of multi-disciplinary nature and importance of biomedical materials, artificial organs and tissue engineering.’

International Journal of Biological Macromolecules

304 pages 234 x 156mm (6 x 9) paperback + CD-ROM 2005ISBN: 978 1 85573 737 2 E-ISBN: 978 1 84569 086 1


Electrospinning for tissue regenerationEdited by L Bosworth and S Downes, University of Manchester, UK


Electrospinning is most commonly associated with textile manufacturing, however recent research and development have proven that the technology can be used to create organ components and repair damaged tissues. This novel approach to tissue repair and regeneration is being widely employed within the biomaterials sector as it produces nanofibres which create the correct physical environment to promote cell migration and new tissue formation. The first part of the book provides an introduction to the field with information on chemistry, process control and regulatory issues. A second group of chapters discuss electrospinning for skin and bone tissue regeneration. A final group of chapters analyse electrospinning for stem cell and wound healing applications.

CONTENTSPart 1 Fundamentals of electrospinning: Introduction to electrospinning; Polymer chemistry; The electrospinning process, conditions and control; Regulatory issues relating to electrospinning. Part 2 Electrospinning for tissue regeneration: Bone tissue regeneration; Cartilage tissue regeneration; Muscle tissue regeneration; Tendon tissue regeneration; Nerve tissue regeneration; Heart valve tissue regeneration; Bladder tissue regeneration; Tracheal tissue regeneration; Dental regeneration; Skin tissue regeneration; Wound dressings. Part 3 Electrospinning for in vitro applications applications: Cell culture systems for kidney research; Cell culture systems for pancreatic research; Cell culture systems for stem cell research.



Degradation rate of bioresorbable materialsPrediction and evaluationEdited by F J Buchanan, Queen’s University Belfast, UK

Woodhead Publishing Series in Biomaterials No. 13CONTENTSPart 1 Introduction: An overview of bioresorbable materials; The biological environment for bioresorbable materials. Part 2 Degradation mechanisms: Synthetic bioresorbable polymers; Natural bioresorbable polymers; Bioresorbable ceramics. Part 3 Bioresorption test methods: In-vitro physicochemical test methods to evaluate bioresorbability; In-vitro biological test methods to evaluate bioresorbability; In-vivo test methods to evaluate bioresorbability; Modelling of the degradation processes for bioresorbable polymers. Part 4 Factors influencing bioresorption: Influence of processing, sterilisation and storage on bioresorbability; Influence of porous structure on bioresorbability: Tissue engineering scaffolds. Part 5 Clinical application: Influence of clinical application on bioresorbability: Host response; Scaffold and implant design: Considerations relating to characterization of biodegradibility and bioresorbability; Drug release from bioresorbable materials.



Artificial cells, cell engineering and therapyEdited by S Prakash, McGill University, Canada

Woodhead Publishing Series in Biomaterials No. 6CONTENTSPart 1 The artificial cell: Introduction to artificial cells: Concept, history, design, current status and future; Polymeric hydrophilic polymers in targeted drug delivery; The artificial cell design: Liposomes; The artificial cell design: Nanoparticles. Part 2 Cell engineering: The cutting edge: Apoptosis and therapeutic opportunity; Bone marrow stromal cells in myocardial regeneration and the role of cell signalling; Musculoskeletal tissue engineering with skeletal muscle-derived stem cells. Part 3 Artificial cells for cell therapy: Artificial cell for oral delivery of live bacterial cells for therapy; Artificial cells in liver disease; Artificial cells as a novel approach to gene therapy; Capillary devices for therapy. Part 4 The clinical relevance of artificial cells and cell engineering: Artificial cells in medicine: with emphasis on blood substitutes; Bone marrow stromal cells as ‘universal donor cells’ for myocardial regeneration therapy; Myocardial regeneration, tissue engineering and therapy; Kidney diseases and potentials of artificial cells; Engineered cells for treatment of diabetes; Drug delivery system for active brain targeting; Artificial cells in enzyme therapy with emphasis on tyrosinase for melanoma in mice; Stem cell and regenerative medicine: Commercial and pharmaceutical implications; Acute lung injury/acute respiratory distress syndrome (ALI/ARDS): The mechanism, present therapy and therapeutic potential of cell-based therapy; Inflammatory bowel diseases: Current treatment strategies and potential for drug delivery using artificial cell microcapsules; Carrier-mediated and artificial-cell targeted cancer drug delivery.



Surface modification of biomaterialsMethods analysis and applicationsEdited by R Williams, University of Liverpool, UK

Woodhead Publishing Series in Biomaterials No. 28CONTENTSPart 1 Surface modification techniques: Surface modification of biomaterials by plasma polymerisation; Surface modification of biomaterials by covalent binding of poly(ethylene glycol) (PEG); Surface modification of biomaterials by heparinisation to improve blood compatibility; Surface modification of biomaterials by peptide functionalisation; Metal surface oxidation and surface interactions; Surface modification of biomaterials by calcium phosphate deposition; Biomaterial surface topography to control cellular response: Technologies, cell behaviour and biomedical applications. Part 2 Analytical techniques and applications: Techniques for analysing biomaterial surface chemistry; Techniques for analysing biomaterial surface structure, morphology and topography; Modifying biomaterial surfaces to optimise interactions with blood; Modifying biomaterials surfaces with bioactives to control infection; Modifying biomaterial surfaces to optimise interactions with soft tissues; Modifying biomaterial surfaces for the repair and regeneration of nerve cells; Modifying biomaterial surfaces to control stem cell growth and differentiation; Modifying biomaterial surfaces to optimise interactions with bone.



Biomaterials

NEW


21st Century quality management and good management practices, 10, 13A biotech manager’s handbook, 3, 12Advanced textiles for wound care, 28Advanced wound repair therapies, 22Allergens and respiratory pollutants, 15An introduction to biotechnology, 2An introduction to pharmaceutical sciences, 7, 19Annotating new genes, 5, 6Application of statistical process control in the pharmaceutical and biotechnology industries, The, 10, 13Artificial cells, cell engineering and therapy, 33

Bacterial cellular metabolic systems, 8Bioactive glasses, 26Bioactive materials in medicine, 26Bioceramics and their clinical applications, 25Biocompatibility and performance of medical devices, 32Bioinformatics for biomedical science and clinical applications, 3, 14Bioinformatics for computer science, 3Biointegration of medical implant materials, 31Biomaterials and devices for the circulatory system, 23Biomaterials and regenerative medicine in ophthalmology, 22Biomaterials and tissue engineering in urology, 22Biomaterials for artificial organs, 21Biomaterials for spinal surgery, 22Biomaterials for treating skin loss, 21Biomaterials in plastic surgery, 21Biomaterials, artificial organs and tissue engineering, 33Biomedical composites, 25Biomedical hydrogels, 27Biomedical imaging, 29Biomedical polymers, 27Biomimetic biomaterials, 25Biosensors for medical applications, 30Biotextiles as medical implants, 27Bio-tribocorrosion in biomaterials and medical implants, 29Bone repair biomaterials, 23

CAPA in the pharmaceutical and biotech industries, 11, 14Cellular response to biomaterials, 30Characterization of biomaterials, 24Clinical research in Asia, 11, 19Clinical research in paediatric psychopharmacology, 16Clinical trial management, 16Coatings for biomedical applications, 26Commercializing the stem cell sciences, 12, 20Computational methods for finding inferential bases in molecular genetics, 3, 5Computer-aided applications in pharmaceutical technology, 4, 18Computer-aided vaccine design, 4Concepts and techniques in genomics and proteomics, 6, 8Contract research and manufacturing services (CRAMS) in India, 6, 11

Decontamination in hospitals and healthcare, 23

Degradation rate of bioresorbable materials, 33Dental biomaterials, 23Deterministic versus stochastic modelling in biochemistry and systems biology, 4Developments in tissue engineered and regenerative medicine products, 19Developments in tissue engineered and regenerative medicine products, 32Diamond based materials for biomedical applications, 25Drug-biomembrane interaction studies, 17Drug-device combination products, 21Durability and reliability of medical polymers, 31

Electroporation-based therapies for cancer, 2, 14Electrospinning for tissue regeneration, 33

Fed-batch fermentation, 7Formulation tools for pharmaceutical development, 16From plant genomics to plant biotechnology, 2, 8Funding of biopharmaceutical research and development, 9

Gene expression analysis in the RNA world, 5, 7

Handbook of medical textiles, 28Hip resurfacing handbook, The, 24Human papillomavirus infections, 8, 15Hyaluronan, 26

Impact of regulation on drug development, The, 6, 9Implantable sensor systems for medical applications, 30In silico protein design, 3Inhaler devices, 21Injectable biomaterials, 27

Joining and assembly of medical materials and devices, 29Joint replacement technology, 22

Lasers for medical applications, 30Lean biomanufacturing, 10, 13Life-cycle of pharmaceuticals in the environment, The, 17

Marine enzymes for biocatalysis, 7Materials science for dentistry, 23MATLAB® in bioscience and biotechnology, 2, 5Medical and healthcare textiles, 28Medical education, training and care delivery in a virtual world, 14Medical modelling, 29Medical robotics, 30Medical textiles and biomaterials for healthcare, 27MEMS for biomedical applications, 31Metals for biomedical devices, 27Microfluidics for biomedical applications, 28Minimized cardiopulmonary bypass techniques and technologies, 31Molecular interfacial phenomena of polymers and biopolymers, 29

Nanomaterials in tissue engineering, 20Nanomedicine, 20

Nanoparticle-based approaches to targeting drugs for severe diseases, 16, 18Nanoparticulate drug delivery, 15Natural-based polymers for biomedical applications, 26NMR metabolomics in cancer research, 15Non-metallic biomaterials for tooth repair and replacement, 30

Ocular transporters and receptors, 17Open source software in life science research, 4, 9Orphan drugs, 10, 17Orthopaedic bone cements, 23Outsourcing biopharma R&D to India, 12

Patent litigation in the pharmaceutical and biotechnology industries, 6, 10Patently innovative, 6, 11Practical leadership for biopharmaceutical executives, 12Preprosthetic and maxillofacial surgery, 24Process validation for the production of biopharmaceuticals, 13, 18Progenitor and stem cell technologies and therapies, 33Protein folding in silico, 5

Regenerative medicine and biomaterials for the repair of connective tissues, 22RNA interference, 7, 16

Shape memory alloys for biomedical applications, 25Smart textiles for medicine and healthcare, 27Standardisation in cell and tissue engineering, 21Stem cell bioprocessing, 13, 20Sterilisation of biomaterials and medical devices, 32Sterilisation of polymer healthcare products, 31Sterilisation of tissues using ionising radiations, 32Successful biopharmaceutical operations, 10Surface modification of biomaterials, 33Surfaces and interfaces for biomaterials, 29

Textiles for hygiene and infection control, 28Therapeutic antibody engineering, 9, 18Therapeutic protein drug products, 8, 19Therapeutic risk management of medicines, 11, 17Tissue engineering using ceramics and polymers, 32Transporters in drug discovery and development, 18

Ultrafiltration for bioprocessing, 7, 13

Wear of orthopaedic implants and artificial joints, 25

Title index


Affatato, S 25Ambrosio, L 22, 25Anand, S C 27Antani, M 6, 11Archer, C 22Arias, J L 16, 18Arinzeh, T 24Atala, A 22, 33Auby, P 16Azevedo, H S 26

Banerjee, A K 11, 17Bartels, V 28Basu, J 19, 32Best, S M 23Bhansali, S 31Bibb, R 29Black, R 23Blanco, C 21Boccaccini, A R 32Bosworth, L 33Bouchard, R A 6, 11Boutrand, J-P 32Brandon, H 21Braund, R 17Breyen, M D 29Buchanan, F J 33Burbulis, N 2, 8Burstein, L 2, 5

Cabral, J M S 13, 20Campbell, P 24Chen, P 29Chin, J Y 12Chirila, T V 22Chowdhury, P R 12Chuan, T J 4Clement, J Q 5, 7Cobo, F 8, 15Cochrane, T 10, 13Courtney, J M 26Cuperlovic-Culf, M 15Curtis, R V 23

Dandekar, P 15Darvell, B W 23De Smet, K 24Deb, S 23Denstedt, J 22Di Silvio, L 30Diaz, J E A 16Diogo, M M 13, 20Djuris, J 4, 18Downes, S 33Driscoll, C 10Driver, M 26

Farrar, D 22Fernandes, T G 13, 20Ferri, J 24Fogher, C 2, 8Forster, M 4, 9Frenz, C M 3

Gaharwar, A K 20Ge, P 7, 16Godbey, W T 2Gokhale, G 6, 11

Gomes, M E 26Gomes, P 30Gough, J 32Gourlay, T 23, 31Guidoin, R 27Gunaydin, S 31Gupta, B S 27

Hacking, S A 20Hammond, W 24Hancock, M J 20Harland, L 4, 9Harvey, O 12, 20Hascall, V C 26Hench, L 33Hennings, G H 6, 9Hernberg-Stahl, E 10, 17Higson, S 30Hinkle, G 7, 16Hodgins, D 30Hopkins, M M 3, 12Hunziker, E 24

Inmann, A 30

Jaffe, M 24Jain, R 15Jelinkova, H 30Jenkins, M 27, 31Jerina, K L 21Jones, J 33Jordan, F 4

Kahol, K 14Kennedy, J F 26, 27, 32King, M W 27Kokubo, T 25

Lacroix, D 23Lai, L 18Laurenzi, I 4Lecca, P 4Lerouge, S 32Lewis, A 21Li, X-J J 28Liang, K-H 3, 14Ludlow, J W 19, 32Lutz, H 7, 13Lysaght, M 21

Mano, J F 26Marques, A P 26Mayall, S 11, 17McCarthy, B J 28Merolli, A 23Meyer, B K 8, 19Miraftab, M 27Mitra, A K 17Miyazaki, S 25Morgan, G E 6, 10Morris, P 29Moulton, G G 7

Narayan, R 25Neves, N M 26Newcombe, A R 13, 18Niinomi, M 27Novobrantseva, T 7, 16

O’Neill, M 3, 12Orgill, D P 21

Patravale, V 15Peake, B M 17Peters, W 21Phillips, G O 26, 32Pignatello, R 17Planell, J A 23Poltronieri, P 2, 8Prakash, S 33Prokopovich, P 21

Qian, H 26

Rajendran, S 27, 28Ralphs, J 22Ramalingam, P 6, 8Ranganathan, S 4Reis, R L 26Revell, P A 22Revett, K 3Rimmer, S 27Rodriguez, J 11, 14Rogers, W 31Roterman-Konieczna, I 5Roy, J 7, 19Ruys, A 25

Sahoo, U 11, 16, 19Salih, V 21Sant, S 20Saraswathy, N 6, 8Sawant, D 16Sharma, C P 31Shimizu, K 8Simmons, A 32Smart, N J 10, 13Stamboulis, A 31Strohl, L M 9, 18Strohl, W R 9, 18Sundararajan, R 2, 14

Tanner, E 22Thillaivinayagalingam, P 13, 18Tolias, P 24Tran, Q-N 3, 5Trincone, A 7

Uchida, S 5, 6

Vadgama, P 29Vallittu, P 30Van Der Straeten, C 24Van Langenhove, L 27Vasudev, A 31Vedvick, T 7Vernon, B 27

Walker, J 23Watson, T F 23Webster, T 21Webster, T J 20Williams, D R 9Williams, M A 15Williams, P A 26, 32Williams, R 33Williams, S 10, 13

Wolf, C 21

Yan, Y 29Ylänen, H O 26Yoneyama, T 25Young, V L 21

Zhao, X 26Zhou, Y 28Zhou, Y N 29

Author index


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