Biosimilars and Pharma Innovations

BCS and IVIVC Based Biowaivers

The term bioweber applies to the regulatory approval process when a document (application) is approved based on evidence of equivalence other than in vivo bioequivalence testing. For solid oral dosage forms, Bioweber is generally based on dissolution tests. • BCS is a scientific framework for classifying drug substances based on water solubility and intestinal permeability. In combination with drug lysis, BCS takes into account three major factors that determine the rate and extent of absorption of solid oral IR dosage forms: lysis, solubility, and intestinal permeability.