Biopharmaceutics Classification System (BCS) and Biowaivers: Role in Drug Product Design

The introduction of the Biopharmaceutics Classification System (BCS) into the Food and Drug Administration is a major step forward to classify the biopharmaceutical properties of drugs and drug products. Based on the mechanistic approaches to the drug absorption and dissolution process, the BCS enables the regulatory bodies to simplify and improve the drug approval process. The knowledge of BCS of drug in a formulation can also be utilized by the formulation scientist to develop a more optimized dosage form.