Forced Degradation Studies

Stability storage and testing

Listen to Dr. Mark Powell as he discusses forced degradation studies. There is currently no harmonised guidance on the conduct of forced degradation studies. This webinar summarizes scientific principles, industry best practice and available guidance (including the ANVISA RDC No. 53 and the accompanying guidance note).

Topics covered include:

  • The science of forced degradation studies
    • Modes of degradation
    • Reaction rate
  • Regulatory expectations
  • Industry best practice