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Session 9A: Innovative Approaches for Stability Programs
Session Chair(s)
Kenneth Waterman, PhD
President
Freethink Technologies, Inc., United States
Stability methodologies for drug substances and drug products continue to evolve both from a scientific and regulatory perspective. This session will explore advances in scientific understanding of stability using the Accelerated Stability Assessment Program (ASAP) and how it impacts decisions in drug development. The session will also explore the changing ways that pharmaceutical companies look to meet their regulatory and ethical commitments while reducing low-value and often time-consuming testing.
Speaker(s)
Global Acceptance Of Lean Stability Strategies: Still Just A Pipe-Dream Or Are We Making Real Progress?
Stephen T Colgan, PhD
Pfizer Inc, United States
Senior Director
Using Scientific Methods To Model Shelf-Life For Solid Drug Substances And Drug Products
Kenneth Waterman, PhD
Freethink Technologies, Inc., United States
President
Using Predictive Stability To Enhance Product Knowledge
Zhixin Jessica Tan, PhD
Amgen Inc., United States
Principal Scientist
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