TRS 1052 - Annex 7: WHO guideline on Biopharmaceutics ClassificationSystem-based biowaivers

Overview

The WHO guideline on Biopharmaceutics Classification System-based biowaivers will supersede the BCS-based biowaiver section of the WHO Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (1). The purpose of this document is to provide recommendations to support the biopharmaceutics classification of active pharmaceutical ingredients (APIs) and the BCS-based biowaiver of bioequivalence studies for finished pharmaceutical products (FPPs).