AAPS Workshop on Stress Testing and Degradation Chemistry
November 10, 2007
San Diego Convention Center
San Diego, CA
ACPE #073-999-07-591-L04
Background Information
Stress testing is recognized as an important part of the drug development process. Recent efforts by the ICH with regard to impurity and photostability guidance has brought increased regulatory scrutiny of impurities and the need to identify and qualify impurities at lower levels. Coupled with the fact that the pharmaceutical industry is making major efforts to reduce the time and resource that it takes to get products to market, the potential for stability and impurity issues that affect the development timeline has increased dramatically. For these reasons, an AAPS workshop dedicated to stress testing has been developed. Stress testing is the main tool that is used to predict problems, develop methods, and identify degradation products/pathways. Since there are no detailed regulatory guidelines that direct how stress testing is performed, stress testing has evolved into an artful science that is highly variable based on the company and/or scientist performing the studies. This course will provide a benchmark of current best practices of experienced pharmaceutical and academic scientists. Questions like "how hot, how long, what conditions are appropriate?" and topics such as mass balance, photostability, oxidative susceptibility, regulatory filing data package guidance, the chemistry of drug degradation and case studies will be addressed.
Goals and Objectives
During the course of this workshop we will cover
- Regulatory perspectives on drug degradation and stress testing
- Fundamentals of photochemistry and oxidative degradation
- Practical aspects of oxidative and photostability stress testing
- Current strategies and protocols for stress testing of pharmaceuticals and industry best practices
- Chemistry of drug degradation and degradation case studies
- Packaging-induced and excipient-induced degradation
- Examples of degradation data in regulatory submissions for mono therapy and combination products
Workshop Agenda
Saturday, November 10
8:15 am
Introductory Remarks
Karen M. Alsante, Ph.D.
Pfizer, Inc.
Steven W. Baertschi, Ph.D.
Eli Lilly and Company
8:30 am
Regulatory Perspective on Drug Degradation and Stress Testing
Linda Ng, Ph.D.
U.S. Food and Drug Administration
9:15 am
Fundamentals of Photochemistry
Guilherme L. Indig, Ph.D.
University of Wisconsin, Milwaukee
10:00 am
Coffee Break
10:20 am
Practical Aspects of Photostability Testing
Allen C. Templeton, Ph.D.
Merck and Company, Inc.
10:50 am
Fundamentals of Oxidative Degradation
Karen M. Alsante, Ph.D.
Pfizer, Inc.
Steve Baertschi, Ph.D.
Eli Lilly and Company
11:20 am
Practical Aspects of Oxidative Susceptibility Testing
Paul A. Harmon, Ph.D.
Merck and Company, Inc.
11:50 am – 1:05 pm
Lunch
1:05 pm
Overview of Stress Testing Protocols: Industry Best Practices
Karen M. Alsante, Ph.D.
Pfizer, Inc.
Steven W. Baertschi, Ph.D.
Eli Lilly and Company
1:35 pm
Drug Degradation Case Studies
Valentino J. Stella, Ph.D.
University of Kansas
2:20 pm
Accelerated Forced Degradation Studies Using Microwaves
Dinos Santafianos, Ph.D.
Pfizer, Inc.
2:50 pm
Coffee Break
3:10 pm
Excipient-induced Chemical Photochemical Degradation
Robert A. Reed, Ph.D.
Xenoport, Inc.
3:40 pm
Packaging-induced Degradation
Mark D. Argentine, Ph.D.
Eli Lilly and Company
Patrick J. Jansen, B.S.
Eli Lilly and Company
4:10 pm
Degradation Chemistry in Regulatory Submission
Dan W. Reynolds, Ph.D.
GlaxoSmithKline
4:40 pm
Panel Discussion
5:00 pm
Adjournment
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