MM.. PPHHAARRMMAACCYY (Pharmacy Practice)

Course structure, Scheme of Instruction and Examination

(Effective from Academic Year 2013-2014)

FACULTY OF PHARMACY

OSMANIA UNIVERSITY

HYDERABAD – 500 007

Proposed M. Pharm (Pharmacy Practice) Syllabus

Course structure, Scheme of Instruction and Evaluation

Semester – I

COURSE

NO. SUBJECTS/ PAPER Th/Pr.

Instruction

Hours/Week Evaluation

DURATION

OF EXT

EXAM.

Theo

ry

Practic

al Int. Ext. Hrs

M PP T.1. 101 Pharmaceutical Analytical Techniques Th. 4 - 30 70 3

M PP T.1-102 Pharmacotherapeutics I Th. 4 - 30 70 3

M PP T.1-103 Pharmacy practice Th. 4 - 30 70 3

M PP T.1-104 Clinical research and clinical toxicology Th. 4 - 30 70 3

M PP P.1-105 Pharmaceutical Analytical Techniques

Pr. - 6 30 70 6

M PP P.1-106 Pharmacotherapeutics I Pr. - 6 30 70 6

M PP T.1-107 Scientific and Technical Writing Tutorial 2 50 Assignments

Seminar + Assignments - 8 - 50

Semester – II

COURSE

NO. SUBJECTS/ PAPER Th/Pr

Instruction

Hours /

Week

Evaluation

DURATIO

N OF EXT.

EXAM.

Theo

ry

Practi

cal Int. Ext. Hrs

M PP T.1-201 Intellectual Property Rights & Regulatory Affairs Th. 4 - 30 70 3

M PP T.1-202 Pharmacotherapeutics-II Th. 4 - 30 70 3

M PP T.1-203 Biopharmaceutics & pharmacokinetics Th. 4 - 30 70 3

M PP T.1-204 Pharmacoepidemiology & pharmacovigilance Th. 4 - 30 70 3

M PP P.1-205 Pharmacotherapeutics-II Pr. - 6 30 70 6

M PP P.1-206 Biopharmaceutics & pharmacokinetics Pr. - 6 30 70 6

M PP T.1-207 Entrepreneurship Management Tutorial 2 50 Assignments

Seminar + Assignments - 8 - 50

Semester III & IV

Diss

ertati

on:

Original research work carried out by the candidate under the guidance of Regular Teaching Faculty / Visiting

Faculty of the Department should be submitted in a bound form.

Evaluation of the Dissertation shall be done by the external & internal examiners appointed by the university

Dissertation Viva-Voce Grade A/B/C/D/F

Dissertation Report Grade A/B/C/D/F

A: Excellent B: Very Good C: Good D: Fair F: Fail

PHARMACEUTICAL ANALYTICAL TECHNIQUES

Subject code: M PP.T.1.101 Period / Week: 4

Sessional: 30 Duration of Exam: 3 hrs

Examinations: 70 Nature of Exam: Theory

UNIT – I

UV-Visible Spectroscopy: Basic principles, interaction of electromagnetic radiation with matter

and its effects (electronic transitions). Concept of chromophore and auxochrome, effect of

conjugation, solvent and pH. Instrumentation (components and their significance). Absorption

spectra of organic compounds and complexes illustrating the phenomenon and its utilization in

qualitative and quantitative studies of drugs including multicomponent analysis. Woodward-

Fieser rules for caculating absortion maximum for unsaturated hydrocarbons. Difference and

derivative spectra.

Infra-Red Spectroscopy: Interaction of infrared radiation with organic molecules and it’s

effects on bonds. Instrumentation- Dispersive IR spectrophotometers and Fourier transform

spectrophotometers. Sample handling for IR spectroscopy. Interpretation of IR spectra. Brief

note on ATR. (Attenuated Total Reflectance).

UNIT – II

Nuclear Magnetic Resonance Spectroscopy: Fundamental principles of NMR, instrumentation

(components and their significance). Chemical shifts concept, spin- spin coupling, spin-spin

decoupling, shielding and deshielding, solvents. signal multiplicity phenomena in high resolution

PMR. Interpretation of PMR spectra.

Brief introduction about Carbon-13 NMR and 2D NMR Spectroscopy.

UNIT – III

Mass Spectrometry: Basic principles and instrumentation (components and their significance).

Ionization techniques, mass spectrum and its characteristics, molecular ion, metastable ions,

fragment ions; fragmentation processes, fragmentation patterns and fragment characteristics in

relation to parent structure and functional groups. Relative abundances of isotopes and their

contribution to characteristic peaks.

UNIT – IV

Chromatographic Techniques: Classification of chromatographic methods based on

mechanism of separation and their basic principles. Gas chromatography: Instrumentation,

column efficiency parameters, derivatisation methods, applications in pharmaceutical analysis.

Liquid chromatography: Comparison of GC and HPLC, instrumentation in HPLC, normal and

reversed phase packing materials, column selection, mobile phase selection, efficiency

parameters, applications in pharmaceutical analysis. Instrumentation and applications of HPTLC,

ion exchange chromatography, gel permeation chromatography, chiral chromatography, flash

chromatography, and supercritical fluid chromatography (SFC).

UNIT – V

Electrophoresis: Principles, instrumentation and applications of moving boundary

electrophoresis, zone electrophoresis (ZE), isotachphoresis, isoelectric focusing (IEF),

continuous electrophoresis (preparative) and capillary electrophoresis. SDS gel electrophoresis

and blotting techniques.

Radio immunoassay and ELISA: Principle, instrumentation, applications and limitations.

Recommended books:

1. Skoog, DA, Holler, FJ, Crouch, SR. Principles of instrumental analysis. 6th

ed., Baba

Barkha Nath printers, Haryana, 2007.

2. Silverstein, RM, Webstar, FX. Spectrometric identification of organic compounds. 6th

ed., John Wiley & Sons (Asia) Pvt. Ltd., Singapore, 2005.

3. William Kemp. Organic spectroscopy, 3rd

ed., Palgrave, New York, 2006.

4. Jag Mohan, Organic spectroscopy: Principles and Applications, 2nd

ed., Narosa

publishing house Pvt Ltd., New Delhi, 2005.

5. Conners KA. A Text book of pharmaceutical analysis, 3rd

ed., John Wiley & Sons,

Singapore, 2004.

6. Willard HH, Merritt LL, Dean JA, Settle FA. Instrumental methods of analysis, 7th

ed.,

CBS Publishers & Distributors, New Delhi, 1986.

7. Pavia DL, Lampman GM, Kriz GS, Vyvyan JA. Introduction to spectroscopy. 4th

ed.,

Brookescole publishers, California, 2008.

8. Sharma BK. Instrumental methods of chemical analysis, 25th

Ed., Goel Publishing

house, Meerut, 2006.

9. Beckett, AH, Stenlake, JB. Practical pharmaceutical chemistry, Part I & II, 4th

ed.,

CBS Publishers & distributors, New Delhi, 2004.

10. Ewing, GW. Instrumental methods of chemical analysis, 5th

ed., McGraw Hill Book

Company, New York, 1985.

11. Schirmer, RE. Modem methods of pharmaceutical analysis, Vol. I & II, 2nd

ed., CRC

Press, Florida, 2000.

PHARMACEUTICAL ANALYTICAL TECHNIQUES (PRACTICAL)

Subject code: M P. P. 1.105 Period / Week: 6

Sessional: 30 Duration of Exam: 6hrs

Examination: 70 - Nature of Exam:

Practical

List of Experiments

1. UV/Visible spectrum scanning of a few organic compounds for UV- absorption and

correlations of structures (5 compounds) and isosbestic point in case of mixtures.

2. Effect of solvents and pH on UV spectrum of drugs (2 experiments).

3. Estimation of multicomponent formulation by UV- Spectrophotometer in formulations.

(2 experiments).

4. Experiments based on the application of derivative spectroscopy. (2 experiments).

5. Experiments based on HPLC (Isocratic and Gradient elution) techniques.

(2 experiments) .

6. Interpretation of drugs by IR spectra.

7. Workshop of spectroscopy: (UV, IR, NMR, MASS) structural elucidation of at least 5

compounds (4 experiments).

8. Separation of protein drug substances by electrophoresis.

9. Any other relevant experiments based on theory.

PHARMACO THERAPEUTICS-I

M.PP T.1.102 Period / Week: 4

Sessional: 30 Duration of Exam: 3 hrs

Examinations: 70 Nature of Exam: Theory

Pathophysiology and applied therapeutics of diseases associated with following

systems/ diseases with special reference to the drugs of choice.

UNIT – I

Cardiovascular system

Hypertension, Congestive cardiac failure, Ischaemic heart disease (Angina,

Myocardial infarction), Arrhythmias, Hyperlipidaemias, Endocarditis, Thromboembolic

disorders, Cardiac arrest – resuscitation.

UNIT – II Respiratory system: Pulmonary function tests, Asthma, Chronic obstructive airways disease,

Drug induced pulmonary diseases. Hydrogen ion hemostasis and blood gases

Endocrine system.

Diabetes, Thyroid diseases, Oral contraceptives, Hormone replacement therapy,

Osteoporosis.

UNIT –III Ophthalmology: Glaucoma, Eye infections

General Prescribing Guidelines for: Paediatric patients; Geriatric patients.

Pregnancy & lactation.

UNIT IV

4. Gastrointestinal system Ulcer diseases, inflammatory bowel diseases, Hepatitis, Jaundice,

Diarrhoea and constipation.

Skin diseases Psoriasis, Eczema and scabies, Drug induced skin diseases

UNIT – V

Oncology

Cell cycle, General principles of cancer chemotherapy, Commonly used cytotoxic

drugs, Chemotherapy of lung cancer, breast cancer, head and neck cancer,

prostate cancer, colorectal cancer, haematological malignancies.

TEXT BOOKS

1. Clinical Pharmacy and therapeutics- Roger and Walker, Churchill Livingstone

publication.

2. Pharmacotherapy : A Patho-physiological approach- Joseph T. Dipiro et al.

Appleton and Lange.

REFERENCE BOOKS

1. Pathologic basis of diseases-Robins SL, W.B.Saunders publication.

2. Pathology and therapeutics for pharmacists: a basis for clinical Pharmacy

Practice.

3. Green and Harris, Chapman and Hall Publication.

4. Clinical Pharmacy and therapeutics- Eric Herfindal, Williams and Wilkins

Publication.

5. Applied Therapeutics: the clinical use of drugs. Lloyd Young and Koda-Kimble

MA [ISBN 0-333-65881-7].

6. Avery’s drug treatment, 4th Edn, 1997, Adis international Limited.

7. Relevant review articles from recent medical and pharmaceutical literature.

PHARMACOTHERAPEUTICS-I (PRACTICALS)

M.PP P.1.106 Period / Week: 6

Sessional: 30 Duration of Exam: 6hrs

Examination: 70 Nature of Exam: Practical

The students are required to be posted to various clinical wards for their exposure

with therapeutic management and other clinical aspects. They are expected to have

experience and do a tutorial as well as case presentation in the following clinical

conditions. The students have to make at least 10 case presentations covering most

common diseases found in the hospital to which the college is attached. The student

should also submit a record of the cases presented. The list of clinical cases presented

should include follow-up of the clinical cases mentioned below from the day of

admission till discharge and presented in the SOAP (Subjective, Objective, Assessment

and Plan) format. The cases may be selected from the following diseases:

1. Cardiology

a) Arrhythmias, b) Ischaemic heart disease, c) Congestive heart failure, d)

Myocardial Infarction, e) Hypertension, f) Thrombo-embolic disease,

g) Endocarditis.

2. Respiratory medicine

a) Asthma, b) Congestive obstructive airways disease (COAD), c) Acute

respiratory failure, d) respiratory tract infections, e) Interstitial lung disease f)

Respiratory aids.

3. Oncology

a) Breast Cancer, b) Lung cancer - Small cell, Non small cell, c) Gastric cancer,

d) Colon cancer, e) Genitourinary tract cancer - Bladder, Prostate, Testicular,

f) Skin cancer, g) Radiation therapy h) Adjunctive therapy - Anti-emetics, Mouth

care, Nutrition, Extravasations, Pain control, Blood products, i) Colony

stimulating factors, j)Infectious disease in immuno-compromised patients,

k) Hypercalcemia l) Cerebral oedema m) Malignant effusions.

4. Endocrinology

a) Diabetes, b) Osteoporosis, c) Thyroid disorders, d) Syndrome of inappropriate

anti-diuretic hormone secretion e) Adrenal disorders.

5. Ophthalmology

a) Ocular infections, b) Conjunctivitis, c) Glaucoma, d) Post-operative

management.

6. Geriatric Medicine

a) Postural hypotension, b) Dementia & delirium, c) Compliance assessment.

7. Paediatrics

a) Acute otitis media, b) Tonsillitis, c) Paediatric asthma, d) Paediatric

gastroenteritis, e) Colic, f) Immunisation, g) Attention deficit disorder, h) Febrile

neutropaenia.

8. Dermatology

a) Psoriasis, b) Dermatitis, c) Drug induced skin disorders.

Assignments:

The students are required to submit a minimum of three written assignments

(1500 to 2000 words) selected from the topics on different disease conditions given to

them. The students are required to discuss both the clinical and therapeutic aspects in the

same.

TEXT BOOKS

1. Clinical Pharmacy and therapeutics- Roger and Walker, Churchill Livingstone

publication.

2. Pharmacotherapy: A Patho-physiological approach - Joseph T. Dipiro et al.

Appleton and Lange.

REFERENCE BOOKS

1. Pathologic basis of diseases-Robins SL, W.B. Saunders publication.

2. Pathology and therapeutics for pharmacists: a basis for clinical Pharmacy

Practice.

Green and Harris, Chapman and Hall Publication.

3. Clinical Pharmacy and therapeutics- Eric T. Herfindal, Williams and

Wilkins Publication.

4. Applied Therapeutics: The clinical use of drugs. Lloyd Young and Koda-Kimble

MA[ISBN 0-333- 65881 – 7].

5. Avery’s drug treatment, 4th Edn, 1997, Adis international Limited.

6. Relevant review articles from recent medical and pharmaceutical literature.

JOURNALS

1. British Medical Journal.

2. New England Journal of Medicine.

3. Annals of Pharmacotherapy.

PHARMACY PRACTICE (THEORY)

M.PP T.1.103 Period / Week: 4

Sessional: 30 Duration of Exam: 3 hrs

Examinations: 70 Nature of Exam: Theory

UNIT I

INTRODUCTION TO CLINICAL PHARMACY, Definition, development and scope, Roles and

responsibilities of clinical pharmacist. DAILY ACTIVITIES OF CLINICAL PHARMACISTS

Drug therapy monitoring (Medication chart view, clinical review, TDM of Cardiovascular drugs,

CNS drugs, pharmacist interventions). Ward round participation, Pharmaceutical care, Drug

information and poison information, Introduction to information resources available, Systematic

approach in answering drug information queries, Critical evaluation of drug information and

literature, Preparation of written and verbal reports, Establishing a Drug Information Centre,

Drug utilisation evaluation (DUE) and review (DUR), Quality assurance of clinical pharmacy

services, Medication errors and various types of medication errors.

UNIT II

PATIENT DATA ANALYSIS

The patient’s case history, its structure and use in evaluation of drug therapy, presentation of

cases, Communication skills including patient medication history interview, patient counseling,

teaching skills, Understanding common medical abbreviations and terminologies used in clinical

practices. Hematological, Liver function, Renal function, Tests associated with cardiac

disorders., Fluid and electrolyte balance, Common tests in urine, sputum, faeces, CSF,

Sensitivity screening for common pathogenic micro-organisms, its significance, resistance in

disease states and selection of appropriate anti-microbial regimens.

UNIT III.

The role of hospital pharmacy department in the hospital and its relationship to other hospital

departments and staff, Pharmacy and Therapeutics Committee, Selection of drugs, Hospital

formulary development and management, Assessing drug efficacy, Assessing and managing drug

safety, evaluating the cost of pharmaceuticals, identifying and addressing drug use problems

including standard treatment guidelines. Other hospital committees such as infection control

committee and research & ethics committee, Hospital Pharmacy Services Purchasing, storage,

stability and safety of drugs, drug distribution, Radiopharmaceuticals handling and packing, IV

additive services and total parenteral nutrition. Inventory control methods (ABC, VED, EOQ,

LEAD TIME, SAFETY STOCK METHODS)

UNIT IV

CONCEPT OF RATIONAL USE OF DRUGS Importance of rational drug use, Pharmacists

role, Drug use indicators, Guidelines for rational prescribing.

EVIDENCE BASED MEDICINE Formulating clinical questions. Searching for the best

evidence. Critical appraisal of the evidence .Applying evidence to patients.

EDUCATION AND TRAINING: Training of technical staff, training and continuing education

for pharmacists, pharmacy students, medical staff and students, nursing staff and students, formal

and informal meetings and lecturers, drug and therapeutics newsletter Ethical issues in

biomedical research – Principles of ethics in biomedical research, good clinical practice [ICH

GCP guidelines], Ethical committee [institutional review board], its constitution and functions,

ethics of publication.

UNIT V

Definition, scope of community pharmacist, Roles and responsibilities of community

Pharmacist, community pharmacy management a) selection of site space, lay out, design

b) staff, materials-coding , stocking c) Legal requirements d) maintenance of various

registers e) use of computers : Business and health care software.

REFERENCES

1. Hospital Pharmacy - Hassan WE. Lec and Febiger publication.

2. Textbook of hospital pharmacy - Allwood MC and Blackwell.

3. Avery’s Drug Treatment, 4th Edn, 1997, Adis international limited.

4. Evidence based medicine: How to practice and teach EBM. Sharon E Straus III

Edition Churchill

1. Clinical Pharmacy Practice by G.Parthasarathi Kavin Nyfort- Hansin

2. Community Pharmacy Basic principle concept by Kamal Dua,Kavita Pabveja

3. Basic skills in interpreting laboratory data – Scott LT, American Society of

Health System Pharmacists, Inc., USA.

CLINICAL RESEARCH & CLINICAL TOXICOLOGY M.PP T.1.104 Period / Week: 4

Sessional: 30 Duration of Exam: 3 hrs

Examinations: 70 Nature of Exam: Theory

Unit: I

Drug development process:

1. Introduction to various approaches to drug discovery 1. Pharmacological 2. Toxicological 3. IND

Application 4. Drug characterization 5. Dosage form

Development of drug Preclinical / Clinical: Introduction to Clinical trials 2. Phases of clinical

trials. 3. Methods of post marketing surveillance 4. Abbreviated New Drug Application submission.

5. Good Clinical Practice – ICH, GCP, Central drug standard control organisation (CDSCO)

guidelines 6. Challenges in the implementation of guidelines

CLINICAL PHARMACOKINETICS: Introduction to clinical pharmacokinetics, Pharmacokinetics

of drug interactions A) Pharmacokinetic drug interactions B) Inhibition and induction of drug

metabolism C) Inhibition of bilary excretion, Dosage adjustment in renal and hepatic disease general

approach for dosage adjustment in renal disease, measurement of GFR, and creatinine clearance,

Extra corporeal removal of drugs. Effect of hepatic disease on Pharmacokinetics

Unit: II

Ethical guidelines in Clinical Research: Composition, responsibilities, procedures of IRB / IEC ,

Overview of regulatory affairs in USA, Europe and India. ,Role and responsibilities of clinical trial

personnel as per ICH GCP a. Sponsor b. Investigators c. Clinical research associate d. Auditors e.

Contract research coordinators f. Regulatory authority , Designing of clinical study documents

(protocol, CRF, ICF, PIC with assignment) ,Informed consent Process , Data management and its

components , Safety monitoring in clinical trials.

Unit: III

General principles of regulatory toxicology. Use of animals in preclinical toxicity studies, role of

preclinical toxicology in drug discovery and development process. Experimental considerations for

assessing possible human risk. Flow chart for development of preclinical testing. Dose conversion

factors, clinical signs toxicity. Preclinical toxicological requirements for biologicals and

biotechnological products; safety analysis; problems specific to recombinant products, toxicokinetics,

principles of GLP as per OECD guidelines for conducting preclinical toxicity studies

UNIT IV

General Principles involved in the management of poisoning, Clinical symptoms and management of

Acute & chronic poisoning with the following agents: Opiates over dose, anti depressants,

barbiturates and benzodiazepines, alcohol: ethanol, methanol, paracetamol and salicylates, NSAIDS,

Pesticide poisioning: organo phosphorous compounds, carbamates, plant poisioning mushroom and

mycotoxins, Venomous snake bites: clinical effects of venoms,general management as first aid,

early manifestations , complications and snake bite injuries

UNIT V

Basics of testing hypothesis

a) Null hypothesis, level of significance, power of test, P value, statistical estimation of confidence

intervals. b) Level of significance (Parametric data)- students t test (paired and unpaired), chi Square

test, Analysis of Variance (one-way and two-way), F-test c) Level of significance (Non-parametric

data)- Sign test, Wilcoxan’s signed rank test, Wilcoxan rank sum test, Mann Whitney U test,

Kruskal-Wall is test (one way ANOVA) d) Correlation- Introduction, Pearsonn’s and

Spearmann’s correlation and correlation co-efficient. e) Regression and its types, Least square

method. f) Introduction to statistical software: SPSS, Epi Info, SAS.

References for clinical research: a. Central Drugs Standard Control Organization. Good

Clinical Practices-Guidelines for Clinical Trials on Pharmaceutical Products in India. New Delhi:

Ministry of Health; 2001. b. International Conference on Harmonisation of Technical

requirements for registration of Pharmaceuticals for human use. ICH Harmonised Tripartite

Guideline. Guideline for Good Clinical Practice.E6; May 1996. c. Ethical Guidelines for

Biomedical Research on Human Subjects 2000. Indian Council of Medical Research, New Delhi.

d. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green, March

2005, John Wiley and Sons. e. Principles of Clinical Research edited by Giovanna di Ignazio, Di

Giovanna and Haynes. f. Clinical Data Management edited by R K Rondels, S A Varley, C F

Webbs. Second Edition, Jan 2000, Wiley Publications. g. Goodman & Gilman: JG Hardman, LE

Limbard, 10th Edn. McGraw Hill Publications, 2001.

Books recommened for clinical toxicology

1. Drug safety Evaluation, Shayne C Gad, Wiley Interscience

2. The toxicologist’s pocket handbook, Michael J derelanko 2nd

Ed,2008,CRC press

3. Relevent OECD guidelines ( Internet resources)

http://www.ingentaconnect.com /content/oecd/16073/2001/00000001/00000004

4. VV Pillay. HAND BOOK OF FORENSIC MEDICINE AND TOXICOLOGY. Thirteenth edition

2003 paras publications , Hyderabad.

Reference books for biostatistics: a. Pharmaceutical statistics- practical and clinical applications,

Sanford Bolton 3rd edition, publisher Marcel Dekker Inc. NewYork. b. Drug Information- A Guide

for Pharmacists, Patrick M Malone, Karen L Kier, John E Stanovich , 3rd edition, McGraw Hill

Publications 2006 c. Biostatistics, P.N. Arora d. Fundamentals of statistics, Elhance. e) Fundamentals

of Biostatistics by Khan and Khanum.

II SEMISTER

IPR & REGULATORY AFFAIRS

M PP.T.1.201 Period / Week: 4

Sessional: 30 Duration of Exam: 3 hrs

Examinations: 70 Nature of Exam: Theory

UNIT – 1 Patents and Intellectual Property Rights (IPR): Definition, scope, objectives, sources of

patent information, patent processing & application, Patents, copyrights, trademarks, salient

features, trade related aspects (TRIPS), international & regional agreements.

UNIT – 2 GATT and WTO: GATT – Historical perspective, objectives, fundamental principles, impact

on developing countries. WTO – objectives, scope, functions, structure, status, membership &

withdrawal, dispute settlement, impact on globalization, India – tasks & challenges.

UNIT – 3 Regulatory Affairs: Indian context – Requirements and guidelines of GMP, understanding of

Drugs and Cosmetic Act 1940 and Rules 1945, with reference to Schedule M, U and Y.

UNIT – 4 Related Quality Systems: Objectives and guidelines of USFDA, WHO and ICH.

Introduction to ISO series.

UNIT – 5 Documentation: Types related to pharmaceutical industry, protocols, ammonizing formulation

development for global filings, NDA, ANDA, CTD, dealing with post-approval changes –

SUPAC, handling and maintenance including electronic documentation.

Recommended books:

1. Good Manufacturing Practices for Pharmaceuticals, S.H.Willig, Vol 78, Marcel

Dekker, NY.

2. Protection of Industrial Property Rights, P. Das and Gokul Das.

3. Law and Drugs, law publ. SN Katju.

4. Original laws published by Govt. of India.

5. Laws of drugs in India, Hussain.

6. New Drug Approval Process, R.A. Guarino, Vol 100, Marcel Dekker, NY.

7. Fda.org, wipo.int, patentlawlinks.com, hc-sc.gc.ca, ich.org, cder.org.

PHARMACO THERAPEUTICS-II

M PP.T.1.202 Period / Week: 4

Sessional: 30 Duration of Exam: 3 hrs

Examinations: 70 Nature of Exam: Theory

UNIT I.

Haematological diseases

Blood and body fluids, Complications of blood transfusion and blood substitutes,

Anaemia, Drug induced haematological disorders

Immunology

Immune disease – pathogenesis, mechanism of action of drugs,

Glucocorticoids – anti-inflammatory, anti-allergic and immunosuppressive

actions in tissue as well as organ transplantation, Vaccines – management of

primary immunodeficiencies

UNIT II.

Bone and joint Disorders

Osteoporosis, rheumatoid arthritis, osteoarthritis, gout, Paget’s disease of bones.

Pain management: Pathophysiology of inflammation and repair, Pain pathways, Analgesics and

NSAIDs, Opiates, Local anaesthetics, Neuralgia, muscle relaxants.

UNIT III.

Nervous system

Epilepsy, Parkinson’s disease, Stroke and transient ischaemic attacks, Headache, Migraine.

Psychiatric disorders

Schizophrenia, Depression, Anxiety disorders, Sleep disorders.

UNIT IV

Infectious diseases

Meningitis, Respiratory tract infections, Gastroenteritis, Pneumonia, Bacterial endocarditis,

Septicaemia, Otitis media, Urinary tract infections, Tuberculosis, Leprosy, Protozoal infections

and helmenthiasis, HIV and opportunistic infections, Fungal infections. sexually transmitted

diseases Syphilis and Gonorrhoea.

UNIT – V

Renal system

Diuretic therapy, Potassium depletion, Hyperkaelemia, Alkalosis, Acute renal failure, Chronic

renal failure, Dialysis, Renal replacement therapy, End-stage renal disease, Drug induced renal

diseases.

TEXT BOOKS

1. Clinical Pharmacy and therapeutics- Roger and Walker, Churchill Livingstone

publication.

2. Pharmacotherapy: A Patho-physiological approach - Joseph T. Dipiro et al.

Appleton and Lange.

REFERENCE BOOKS

1. Pathologic basis of diseases-Robins SL, W.B. Saunders publication.

2. Pathology and therapeutics for pharmacists: a basis for clinical Pharmacy

Practice.

Green and Harris, Chapman and Hall Publication.

3. Clinical Pharmacy and therapeutics- Eric T. Herfindal, Williams and

Wilkins Publication.

4. Applied Therapeutics: The clinical use of drugs. Lloyd Young and Koda-Kimble

MA[ISBN 0-333- 65881 – 7].

5. Avery’s drug treatment, 4th Edn, 1997, Adis international Limited.

6. Relevant review articles from recent medical and pharmaceutical literature.

JOURNALS

1. British Medical Journal.

2. New England Journal of Medicine.

3. Annals of Pharmacotherapy.

PHARMACO THERAPEUTICS-II PRACTICALS

M PP.T.1.205 Period / Week: 4

Sessional: 30 Duration of Exam: 3 hrs

Examinations: 70 Nature of Exam: Theory

The students are required to be posted to various clinical wards for their exposure with

therapeutic management and other clinical aspects. They are expected to have experience and do

a tutorial as well as case presentation in the following clinical conditions. The students have to

make at least 10 case presentations covering most common diseases found in the hospital to

which the college is attached. The student should also submit a record of the cases presented.

The list of clinical cases presented should include follow-up of the clinical cases mentioned

below from the day of admission till discharge and presented in the SOAP (Subjective,

Objective, Assessment and Plan) format. The cases may be selected from the following diseases:

1. Gastroenterology

a) Diarrhoea, Constipation, b) Acid peptic disease, c) Hepatic diseases - Hepatitis,

Cirrhosis & Drug induced hepatic disorders, d) Oesophageal reflux, e)

Helicobacter pylori induced gastric disorders.

2. Rheumatology

a) Rheumatoid arthritis, b) Gout, c) Degenerative joint disease - Temporal

arthritis, Polymyalgia rheumatica etc., d) Systemic lupus erythmatosis.

3. Surgery

a) Prophylactic Antibiotics, b) Anticoagulants - Heparin, Warfarin, c)

Thrombolytics, d) Adjunctive therapy, e) Pre-operative medications, f)Analgesia.

4. Haematology

a) Leukaemias, b) Lymphomas - Hodgkin’s, Non-Hodgkin’s, c) Multiple

myeloma, d) Anaemia, e) Bleeding disorders.

5. Infectious Disease

a) Respiratory tract infections b) Tuberculosis c) Urinary tract infections,

d) Joint and borne infections, e) Skin and Soft tissue infections.

6.Critical Care

a) Haemodynamic monitoring , b) Parenteral & enter nutrition,

c) Pharmacotherapy of ventilated patients, d) Shock - Septic, Cardiogenic.

7. Renal

a) Acute renal failure, b) Chronic renal failure, c) Drug induced renal disease.

8. a) Convulsive disorder b) Parkinson ‘s disease, c) Neuro-degenerative disorders, d) Stroke,

e) TIAs.

9. Psychiatry

a) Uni-polar and bipolar disorders, b) Anxiety, c) Psychosis, d) Alcohol abuse,e) Drug abuse

Assignments:

The students are required to submit a minimum of three written assignments (1500 to 2000

words) selected from the topics on different disease conditions given to them. The students are

required to discuss both the clinical and therapeutic aspects in the same.

BIOPHARMACEUTICS AND PHARMACOKINETICS

Subject Code : M.PP.T.1.203 Sessional : 30

Period / Week: 4 Examinations : 70

Nature of Exam: Theory Duration of Exam: 3 hrs

UNIT -I

Bioavailability and Bioquiovalence: Objectives, bioavailability & variations, measurements of

bioavailability, enhancing bioavailability, concepts of equivalents, official bioequivalence

protocols & therapeutic equivalence.

UNIT -II

Drug Absorption: General consideration, absorption / drug transport mechanisms, role factors

affecting absorption, absorption of drug non-peroral routes, methods of determining absorption-

in-vitro, in-situ, and in-vivo methods.

Drug Distribution: Factors affecting, protein & tissue binding, kinetics, determination of rate

constants & different plots (direct, Scatchard, & reciprocal).

UNIT -III

Pharmacokinetcs: Parameters & determination, pharmacokinetic models – one compartment,

multi compartment in IV bolus, IV infusion & extra vascular, drug & metabolites levels in blood,

urine and other biological fluids. Integration of kinetics.

Application of pharmacokinetics in new drug development, design of dosage forms and novel

drug delivery systems.

UNIT - IV

Drug Disposition and Excretion: Biotransformation, factors affecting biotrasformation,

Phase I & Phase-II reactions.

Clearance: Concept, renal, non-renal clearance, mechanism, determination, % drug

metabolized, different volume of distribution.

UNIT – V

Pharmacokinetics of Multiple Dosing: Various terminology, determination, adjustment of

dosage in renal & hepatic impairment, individualization of therapy, therapeutic drug monitoring.

Non-linear kinetics: Cause of non-linearity, estimation of various parameters, bioavailability

of drugs that follow non-linear kinetics. Chronopharmacokinetics & pharmacokinetics of elderly

and infants.

Recommended books

1. Biopharmaceutics and Clinical Pharmacokinetics, Mile Gibaldi, Lea and Febriger,

Philadelphia.

2. Current concepts in Pharmaceutical Sciences, Swarbrick, Lea and Febriger, Philadelphia.

3. Theory & Practice of Industrial Pharmacy, L.Lachman, Varghese Publ, Bombay.

4. Clinical Pharmacokinetics, Rowland and Tozer, Lea and Febriger, Philadelphia.

5. Biopharmaceutics and Clinical Pharmacokinetics, Niazi, Prentice Hall, London.

6. Remingtons Pharmaceutical Sciences, Mack & Co.

7. Biopharmaceutics & Clinical Pharmacokinetics, DM Brahmankar, Vallabh, Delhi.

8. C.V.S.Subrahmanyam, Textbook of Biopharmaceutics and Pharmacokinetics, 2009,

Vallabh Prakashan, Delhi.

BIOPHARMACEUTICS AND PHARMACOKINETICS

Subject Code : M.PP.P.1.206 Sessional : 30

Period / Week: 6 Examinations : 70

Nature of Exam: Practicals Duration of Exam: 6 hrs

Suggested experiments

1. Comparative dissolution studies on different dosage forms for drugs.

2. Effect of pH / particle size on dissolution studies.

3. Plasma protein binding studies on different drugs.

4. Estimation of pharmacokinetic parameters in urine / serum samples.

5. Estimation of creatinine clearance.

6. Estimation of pharmacokinetic parameters for the given urinary excretion data.

7. Estimation of pharmacokinetic parameters for the given oral absorption data.

PHARMACOEPIDEMIOLOGY AND PHARMACOVIGILANCE (THEORY)

Subject Code : M.PP T.1.204 Sessional : 30

Periods/Week : 4 Examination : 70

Nature of Exam : Theory Exam Duration : 3 Hrs

Unit: I

Pharmacoepidemiology:

Definition and scope: Origin and evaluation of pharmacoepidemiology need for

pharmacoepidemiology, aims and applications.

Measurement of outcomes in pharmacoepidemiology Outcome measure and drug use

measures Prevalence, incidence and incidence rate. Monetary units, number of prescriptions,

units of drugs dispensed, defined daily doses and prescribed daily doses, medication adherence

measurement, Concept of risk in pharmacoepidemiology Measurement of risk, attributable

risk and relative risk, time-risk relationship and odds ratio

Unit: II

Pharmacoepidemiological methods Includes theoretical aspects of various methods and

practical study of various methods with the help of case studies for individual methods Drug

utilization review, case reports, case series, surveys of drug use, cross – sectional studies, cohort

studies, case control studies, case –cohort studies, meta – analysis studies, spontaneous reporting,

prescription event monitoring and record linkage system. Sources of data for

pharmacoepidemiological studies Ad Hoc data sources and automated data systems. Selected

special applications of pharmacoepidemiology Studies of vaccine safety, hospital

pharmacoepidemiology, pharmacoepidemiology and risk management, drug induced birth

defects.

Unit: III

Phrmacoeconomics:

Definition, history, needs of pharmacoeconomic evaluations Role in formulary management

decisions Pharmacoeconomic evaluation Outcome assessment and types of evaluation includes

theoretical aspects of various methods and practical study of various methods with the help of

case studies for individual methods: Cost – minimization, cost- benefit, cost – effectiveness, cost

utility Applications of Pharmacoeconomics Software and case studies

UNIT IV

Pharmacovigilance

A. Scope, definition and aims of pharmacovigilance, Definitions of the following:

Adverse drug reaction (ADR), Adverse events (AE), serious adverse event (SAE),

Serious adverse reaction (SAR), Suspected unexpected serious adverse reaction (SUSAR)

B. Adverse drug reactions – Classification, mechanism, Predisposing factors, causality

assessment (different scales used)

C. Current methods of Pharmacovigilance, Signal detection in Pharmacovigilance,

Post marketing surveillance.

D. Reporting, Evaluation, Monitoring, Prevention & Management of ADRs

E. Role of pharmacist in management of ADR.

F. Setting up of a pharmacovigilance center, benefit-risk assessment in Pharmacovigilance

UNIT V

a. FDA rules and regulations for reporting ADRs for various classes of drugs

b. Common databases used in pharmacovigilance (eg: ARGUS 15.1 version, Vigi base)

c. Various countries ADR reporting systems( eg: India, EU, Switzerland, U.S.A)

d. The council for international organizations of medical sciences (CIOMS) ADR

reporting system, Pharmacovigilance programme in india(PVPI)

REFERENCE BOOKS:

1. A textbook of Pharmacoepidemiology by brian l. Strom and stephen e. Kimmel

University of Pennsylvania, Philadelphia.

2. Cobert’s manual of Drug safety and Pharmacovigilance Second edition by Barton Cobert

3. Text Book of Pharmacovigilance by S.K. Guptha Jaypee publications

4. Essentials of Pharmacoeconomics Karen Rascati (Author) Wolters kulwer Lippincott

Williams Publications

5. Principles of Pharmacoeconomics second edition W Harvey whitney books company

J. Lyle Bootman (Author, Editor), Raymond J. Townsend (Editor), William F. McGhan

(Editor)