Shelf-Life Evaluation and Extrapolation

Stability storage and testing

This webinar explains how to set a retest period for a drug substance or shelf life for the drug product. It also describes how extrapolation can be applied to propose a retest period or shelf life for a drug product that extends beyond the period covered by real-time stability data. It covers regulatory guidance, poolability of stability data and appropriate statistical models for shelf-life evaluation.

Topics covered include:

  • Overview of ICH Q1E – Evaluation for Stability Data
  • Shelf-life extrapolation
  • Statistical background to ICH Q1E
  • Evaluating poolability of stability data – analysis of covariance
  • Examples – potency and impurity trends