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Session 7A: Science, Risk-Based Approaches to Post-Approval Stability Testing
Session Chair(s)
Chi-Wan Chen, PhD
Pfizer, Inc., United States
This session will examine the need for, and the benefit of, establishing an ICH guideline on science- and risk-based approaches to stability testing for post-approval CMC changes or stability commitment. An outline of a proposal for an ICH guideline on this topic will be described. Predictive tools such as statistical modeling, and Accelerated Stability Assessment Program (ASAP), will be discussed. Utility of prior knowledge to justify reduced stability protocols for legacy products will be presented.
Speaker(s)
The Case for a New ICH Guideline on Science- and Risk-Based Approaches to Stability Testing for Post-Approval CMC Changes
Chi-Wan Chen, PhD
Pfizer, Inc., United States
Predictive Stability Approaches to Assessing Critical Attributes of Pharmaceutical Products
Brian Patrick Regler, PhD
Merck, United States
Associate Principal Scientist
Leveraging Stability Profiles to Justify a Reduced Stability Program for Legacy Products
Anthony Rainosek
Baxter Healthcare, United States
Right-Sizing Post-Approval Stability Commitments: A Case-Study and Considerations
Donnie Pulliam, MBA
Biogen, United States
Manager, Global Regulatory Affairs-CMC