A one day workshop in which the current requirements and guidelines for demonstrating bioequivalence are reviewed and analysed. This workshop will involve discussion of :-

  • The different studies that may be used to demonstrate bioequivalence.
  • The requirements for bioequivalence for different dosage forms.
  • An in depth look at the Comparative Bioavailability study for proving bioequivalence.
  • What is meant by the 90% Confidence interval and how it is applied.
  • Completing the BTIF
  • Bioequivalence requirements for registration amendments
  • Comparative dissolution and BCS biowaivers