ABSTRACT
This chapter covers the most signicant aspect of the scope of this book-the relevance of bioequivalence (BE) testing. Establishing BE between two products extends to several types and situations:
• Prototype formulations during early development and pivotal clinical trial formulations • Innovator formulations that differ from their new drug application (NDA) formulations as
a result of scale-up and postapproval changes (SUPAC) • Implementation of improved manufacturing technologies • Scale-up changes in manufacturing locations • Multisource products led for approval under abbreviated new drug application (ANDA)
The demonstration of BE is assumed to represent product quality throughout its life cycle forming the basis for waiver of conducting expensive clinical studies to demonstrate safety and efcacy.
