Join Dr. Mark Powell as he discusses shelf life evaluation and extrapolation.
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
This webinar is hosted by Q1 Scientific, a global leader in environmentally controlled stability storage and sample management.