ABSTRACT
Demonstration of bioequivalence is a critical requirement for gaining marketing authorization of new drugs and generics. These requirements are specified in the Code of Federal Regulations, Title 21, Part 320 (21 CFR Part 320) as they apply to dosage forms intended for oral administration. Substantial changes to these guidelines have been contemplated. In the discussion that follows, an overview of the guidelines that will soon become effective is provided. Manufacturers contemplating the development of new drug products should pay close attention to the changes described in Sections II.B. and II.C. regarding bioavailability (BA) or bioequivalence (BE) studies.
