Accelerated Predictive Stability Testing: Accelerating Registration Phase and Application of Reduced Designs for Shelf-Life Determination of Parenteral Drug Product

Objectives: This article explores the applicability of the accelerated stability assessment program (ASAP) in stability studies for parenteral medications. Conventional stability testing requires extensive evaluation over the entire shelf life of a product, which can be very time-consuming. In contr...

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Bibliographic Details
Main Authors: Lara Pavčnik, Mateja Prunk, Tina Trdan Lušin, Robert Roškar
Format: Article
Language:English
Published: MDPI AG 2025-01-01
Series:Pharmaceutics
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Online Access:https://www.mdpi.com/1999-4923/17/2/160
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