Biopharmaceutics classification system- basis for waiver of in-vivobioavailability and bioequivalence studies

Trivikram Rawat and I. P. Pand

Abstract

The Biopharmaceutical classification system (BCS) w as introduced by Amidon et al in 1995 to reduce the need for in vivo bioequivalence (BE) studies, utilization of in vitro dissolution tests as a surrogate for in v ivo bioequivalence studies. This step certainly reduces timelines in t he drug development process, both directly and indi rectly, and reduces unnecessary drug exposure in healthy volunt eers, which is the normal study population in BE st udies. The principles of the BCS classification system can be applied to NDA (New Drug Application) and ANDA (Abb reviated New Drug Application) approvals as well as to scale -up and post approval changes in drug manufacturing .