![]() ![]() ![]() 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. The Biopharmaceutics Classification System: The BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability. Biopharmaceutical classification system (BCS) is a drug development tool that is based on correlation of solubility with their bioavailability in human body and allows estimation of the contributions of three major factors, dissolution, solubility, and intestinal permeability, which affect oral drug absorption from immediate release (IR) solid oral products. FDA has issued a final guidance entitled Waiver of In-vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.
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