understanding design of experiments doe
TRANSCRIPT
27-28 February 2015 Hotel Suba International
Plot 211, Chakala, Sahar Road Opp. Cigarette Factory, Andheri (East), Mumbai
Understanding Design of Experiments DoERobustness of a Pharmaceutical Process and
Analytical Method
This course aims to explain the basics of DoE using factorial and fractional DoE. Learn how to set up an experimental design and how to explore the effect of factors that influence either a process or an analytical method while taking into account interactions between the factors. To better assimilate the DoE principles, the calculation of main effects and factors interactions by simple hand calculations and with Excel will be done. Minitab software program will demonstrate how to create a variety of DOE designs and how to analyse and interpret them. Multiple exercises and examples from pharmaceutical development and laboratory analysis such as robustness studies with be solved by the participants. The participants will learn how to interpret the output of a DOE program.
COURSE OVERVIEW
Demonstration with a software program - Minitab 17Each participant should bring a laptop with Excel and a previously
downloaded 30 day free-trial Minitab 17 program from http://www.minitab.com. This program should be downloaded
on a laptop a few days before the beginning date of the course and verified that it works on the laptop.
RAPHAEL BARRAPHAEL BAR
Raphael Bar is presently a pharmaceutical consultant at BR Consulting for the Pharma and bio-pharma industries.Dr. Raphael Bar was the President of Israel Chapter of the Parenteral Drug Association (PDA) and a member of the organizing committee if Israel Analytical Chemistry Society since 1996.
He received his Ph.D. in Chemistry from The Hebrew University after combined graduate studies in Applied Chemistryand Chemical Engineering from Virginia Tech, USA. Following this, Dr. Bar has also competed a 3-year post-doctoraltraining in Biotechnology from UVA, USA.
Dr. Bar joined Teva Pharmaceuticals, Israel in 1995 and for three years, he was Head of the Analytical R&D Laboratory,He was involved in preparation of various ANDA files and underwent several pre-approval FDA inspections. In 1998,he joined pharmos where he managed the Quality Control and R&D laboratory till September 2007. As Senior Director of Analytical Development, Dr. Bar was actively involved in preparation of CMC packages for several Phase 1, several Phase2 and one Phase 3 clinical trial studies.
The main areas of experience and expertise of Raphael Bar revolve around analytical and bioanalytical method development and validation, stability studies, statistical evaluation of laboratory data and bioassays, sterile production of parenterals and QA/RA issues. He particularly developed an expertise in stability studies, from initial testing to final statistical analysis of stability data. Raphael Bar conducted formal stability studies of drug substance and product according to ICH/FDA guides. He also conducted and oversaw GLP studies of metabolites identification and quantitation in biological matrices, while being involved in IND/NDA files preparations.
Dr. Bar has been teaching courses to QC and R&D personnel from pharmaceutical companies for more than ten years bothin Israel and overseas. Dr. Bar authors over 40 peer-reveiwed papers, of which the last two papers address statistical analysisof drug stability data.
RAPHAEL BARWorkshop Leader
27-28 February 2015 Hotel Suba International
Plot 211, Chakala, Sahar Road Opp. Cigarette Factory, Andheri (East), Mumbai
Understanding Design of Experiments DoERobustness of a Pharmaceutical Process and
Analytical Method
PROGRAM OUTLINE
1. Introduction:
2. DOE by hand calculations first!
3. DOE experiments with Minitab
DOE and Quality-by-Design Regulations (EU and FDA) DOE in validation of analytical methods DOE in process validation
Factorial Experiments Two and three factorial designs Manual calculation of main effects Manual calculation of interactions Are the effects significant? Making replicate experiments Adding experiments at center points Using known variability Exercises with Excel
Two factor full DOE experiments with Minitab Interactions between two factors Plotting Main effects and Interactions Interpretation of DOE Minitab output Does the linear fit the model? Significance of p values Exercises with Minitab Exercises in interpretation of Minitab outputs
27-28 February 2015 Hotel Suba International
Plot 211, Chakala, Sahar Road Opp. Cigarette Factory, Andheri (East), Mumbai
Screening experiments Fractional experiments Full Factorial experiments Optimization experiments Robustness experiments of a process/method
Two factor experiments with Minitab Aliasing in DOE experiments Resolution of DOE experiment Plackett-Burman designs Exercises with Minitab: a. Robustness study with fractional DOE b. Excipient-API compatibility study with Plackett-Burman design
2 factorial experiments with RSM Contour plot Surface plot Concept of Design Space Exercise: Optimization of drug solubility with RSM design
Types of designs Interpretation of Minitab output Exercise: Effect of mixtures of excipients on tablet hardness
4. Strategy of DOE in the pharmaceutical setting
5. Fractional DOE experiments with Minitab
6. Optimization with Response Surface Methodology
7. Design of mixtures
2
Understanding Design of Experiments DoERobustness of a Pharmaceutical Process and
Analytical Method
By Phone | fax | e-mail | “Last Date for Registration : 25th February 2015”
27-28 February 2015 Hotel Suba International
Plot 211, Chakala, Sahar Road Opp. Cigarette Factory, Andheri (East), Mumbai
Participants should bring along a Laptop individually or to be shared between 2 Persons.Laptops would be provided optionally on a daily charges of Rs. 2000/- + Service Tax per Laptop.
Understanding Design of Experiments DoERobustness of a Pharmaceutical Process and
Analytical Method