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