Course description
This course will evaluate every aspect of BA/BE from the regulations and types of protocol studies to bioanalysis, statistical analysis and reporting. The course will also examine the different types of biowaivers and data needed to provide clear strategy to biowaiver application.
This practical course will provide understanding of BABE design including all practical aspects related to bioavailability & bioequivalence. Thanks to different case studies, participants will be understanding about the requirements of the BA/BE studies as well as the determination of pharmacokinetic parameters, the possibility of biowaivers and the related regulatory and legal aspects. In addition, the participants will learn about development of dissolution test and the need of dissolution to support BA/BE studies.
