Biopharmaceutics Classification System: A Regulatory Approach

The Biopharmaceutics Classification System (BCS) is the result of continuous efforts in mathematical analysis for the elucidation of the kinetics and dynamics of the drug process in the gastrointestinal tract (GIT) for NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) filings and biowaivers. This step reduces timelines in the new drug development process, both directly and indirectly, reduces unnecessary drug exposure in healthy volunteers, and increases impact for the replacement of certain bioequivalence (BE) studies with in vitro dissolution tests.