Utilization of risk-based predictive stability within regulatory submissions; industry's experience

• Main Authors: Megan McMahon (Author), Helen Williams (Author), Elke Debie (Author), Mingkun Fu (Author), Robert Bujalski (Author), Fenghe Qiu (Author), Yan Wu (Author), Hanlin Li (Author), Jin Wang (Author), Cherokee Hoaglund-Hyzer (Author), Donnie Pulliam (Author)
• Format: Book
• Published: SpringerOpen, 2020-05-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract Risk-Based Predictive Stability (RBPS) tools, such as the Accelerated Stability Assessment Program (ASAP) and other models, are used routinely within pharmaceutical development to quickly assess stability characteristics, especially to understand mechanisms of degradation. These modeling to...