The Role of BCS (Biopharmaceutics Classification System) and BDDCS (Biopharmaceutics Drug Disposition Classification System) in Drug Development

摘要

BCS and BDDCS are complimentary, not competing, classification systems that aim to improve, simplify, and speed drug development. Although both systems are based on classifying drugs and NMEs into four categories using the same solubility criteria, they differ in the criterion for permeability and have different purposes. Here the details and applications of both systems are reviewed with particular emphasis of their role in drug development.