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

ABSTRACT:

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 contrast, ASAP provides an efficient approach to support drug product development and expedite regulatory procedures.

Methods

The study involved subjecting the medication to different stress and long-term stability conditions and monitoring the formation of degradation products. A systematic methodology was employed to evaluate the stress stability data of the parenteral medication using various designs (full and reduced). ASAP models were then developed from these data and assessed usi

SUBMITTER: Pavcnik L 

PROVIDER: S-EPMC11858995 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature