The Premier Conference on Forced Degradation Studies: Best Practices for the Pharmaceutical Industry

Venue: The Westin Princeton at Forrestal Village

Location: Princeton, New Jersey, United States

Event Date/Time: Feb 24, 2004 End Date/Time: Feb 25, 2004
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Welcome to the first conference dedicated to Forced Degradation. The mission of this program is to continue efforts on influencing and benchmarking the external environment with respect to best practices for conducting forced degradation studies. The conference provides an overview of stress testing practices in the pharmaceutical industry and a thorough comparative analysis of approaches to stress testing based on an extensive benchmarking study conducted with 20 pharmaceutical companies. This survey sponsored by Pfizer and Eli Lilly and Company provided interesting results in the areas of harmonization,as well as diversity in forced degradation practices.

The pharmaceutical industry’s considerable interest in this topic led to the publication of an Available Guidance and Best Practices for Conducting Forced Degradation Studies in February of 2000. Although the concept of stress testing is not new to the pharmaceutical industry, the procedure was not clearly defined until the International Conference on Harmonization (ICH) provided a definition in its guidance on stability. The ICH guideline indicates that stress testing is designed to help, “determine the intrinsic stability of the molecule by establishing degradation pathways in order to identify the likely degradation products and to validate the stability-indicating power of the analytical procedures used.” This ICH definition leaves the details of the investigations to the pharmaceutical researcher; therefore, the stress testing practices that companies use can vary tremendously and can have a significant impact on the analytical methodology used throughout the industry.

As mentioned above, this conference will provide an overview of stress testing practices in the pharmaceutical industry and detail key findings from the stress testing benchmarking study. The program also provides a summary of available regulatory guidance and an informative teaching session on the chemistry of drug degradation to help pharmaceutical scientists become more familiar with the major mechanisms of chemical decomposition in the context of common functional groups.

The most valuable aspect of the conference is the breakout sessions,where we plan to discuss the following topics at greater length:

Stress testing study design
Types of stress conditions and experimental approaches
Timing of stress testing (drug substance and drug product)
Summary of requirements at the IND phase and for the marketing application
Stress testing function: Company organization used to conduct stress testing
Standard operating procedures and protocols on GMP issues
Throughout this Forced Degradation conference, we hope to build on the PhRMA AAP document and take the next steps towards a degradation best practices guide. We want to establish a degradation discussion group where pharmaceutical scientists in the field can get useful guidance on degradation, an area with limited regulatory guidance. Please register early as we expect the event to sell out. We look forward to greeting you on February 24th in Princeton!