Assessing Drug Product Shelf Life Using the Accelerated Stability Assessment Program: A Case Study of a GLPG4399 Capsule Formulation

Assessing Drug Product Shelf Life Using the Accelerated Stability Assessment Program: A Case Study of a GLPG4399 Capsule Formulation

<b>Objective:</b> To evaluate and project the shelf life of GLPG4399, an early-phase clinical drug formulation by applying the Accelerated Stability Assessment Program (ASAP) approach. <b>Methods:</b> Forced degradation conditions were implemented to identify the stability-li...

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Bibliographic Details
Main Authors: Dattatray Modhave, Sara Vrielynck, Kevin Roeleveld
Format: Article
Language:English
Published: MDPI AG 2024-10-01
Series:Pharmaceutics
Subjects:
stability testing
ASAP
degradation kinetics
shelf life
chemical stability
Online Access:https://www.mdpi.com/1999-4923/16/11/1400
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