You are here : Home News News Waiver of In Vivo Bioavailability and Bioequivalence Studies

Waiver of In Vivo Bioavailability and Bioequivalence Studies

The BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability. When combined with the dissolution of the drug product, the BCS takes into account three major factors that govern the rate and extent of drug absorption from IR solid oral dosage forms: (1) dissolution, (2) solubility, and (3) intestinal permeability.

Download PDF