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Stability Study Design – Bracketing and Matrixing

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Stability programmes are a costly undertaking, especially for products that have multiple strengths and packaging configurations, where a full study design will require every configuration to be evaluated for three registration batches at each time point.  The use of reduced study designs such as bracketing and matrixing can reduce the cost of formal stability studies.  This webinar describes when the use of such approaches is allowable, together with their associated benefits and risks. Topics covered include:

  • Overview of ICH Q1D – Bracketing and Matrixing Designs
  • Bracketing study designs
  • Bracketing study risks
  • Matrix study designs
  • Matrix study risks
  • Combined bracketing and matrix study designs
  • Summary of risks and benefits

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.