Utilization of risk-based predictive stability within regulatory submissions; industry’s experience
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...
Main Authors: | , , , , , , , , , , |
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Format: | Article |
Language: | English |
Published: |
SpringerOpen
2020-05-01
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Series: | AAPS Open |
Subjects: | |
Online Access: | http://link.springer.com/article/10.1186/s41120-020-00034-7 |