webinar register page

Shelf life evaluation and extrapolation
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.

Feb 25, 2021 02:00 PM in Dublin

Webinar logo
Webinar is over, you cannot register now. If you have any questions, please contact Webinar host: Q1 Scientific.