Stability Study Design: Bracketing and Matrixing

Stability storage and testing

Stability programs 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