Program Focus
Learn & understand the fundamentals of
bioavailability, bioequivalence and biowaivers
Determine when a BA/BE study is obligatory
Examine bioanalytical method validation and maintain compliance
requirements in USA and EU
Learn to interpret biowaiver regulations in
USA and EU and meet compliance
Develop strategies for testing highly variable
drugs and design studies for different types
of formulation
Assess the regulations in the EU, USA, Russia,
Brazil, China and Japan for bioequivalence
studies to gain a global perspective and maintain compliance
Evaluating the risk associated with submitting
a biowaiver