A Review On Biopharmaceutics Classification System-Based Biowaivers

Abstract

This review discusses the Biopharmaceutics Classification System (BCS) and its role in biowaivers for generic drug development. The BCS classifies drugs into four categories based on their solubility and permeability characteristics. The BCS classification system aids in determining regulatory requirements for generic drug development and guides formulation strategies to enhance drug solubility, permeability, and oral bioavailability. It primarily applies to immediate-release, orally administered dosage forms. Excipient effects on absorption are also considered, and specific criteria must be met for a drug product to qualify for a BCS-based biowaiver.