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Shelf Life Evaluation and Extrapolation

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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

Guest speaker

Dr. Mark Powell, Director at MP Scientific

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of companies with responsibility for analytical development and equipment qualification.

In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes as well as establishing collaborations with academia and instrument manufacturers. In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits.

He is in demand as a trainer in topics such as chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies, method validation, extractables and leachables, and root cause analysis.