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...

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Detalhes bibliográficos
Main Authors: Megan McMahon, Helen Williams, Elke Debie, Mingkun Fu, Robert Bujalski, Fenghe Qiu, Yan Wu, Hanlin Li, Jin Wang, Cherokee Hoaglund-Hyzer, Donnie Pulliam
Formato: Artigo
Idioma:Inglês
Publicado em: SpringerOpen 2020-05-01
Colecção:AAPS Open
Assuntos:
Risk-based predictive stability
RBPS
Clinical shelf-life
Predictive
Regulatory feedback
Acesso em linha:http://link.springer.com/article/10.1186/s41120-020-00034-7
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