Stability Studies Throughout the Product Life Cycle

Stability storage and testing

Join Dr. Mark Powell as he looks at the various stability studies conducted from the start of pharmaceutical development to the manufacture of marketed product. Dr. Mark Powell also explains the purpose of each study and highlights some of the potential pitfalls.

Topics covered include:

  • Aims of stability evaluation
  • The effect of environmental factors and the primary pack
  • API stability
  • Excipient compatibility
  • Prototype stability (including accelerated stability using the ASAP model and stress stability studies)
  • Bulk hold studies
  • In-use stability
  • Registration stability
  • Shipping excursion studies