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. INTRODUCTION An ANDA (21 CFR 314) contains data for the review and ultimate approval of a generic drug product. Generic drug applications are termed “abbreviated” because they generally are not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their products are bioequivalent (i.e., performs in the same manner as the innovator drug). Bioequivalence studies are conducted on generic drug products in place of animal studies, clinical studies, or bioavailability studies. In vitro–in vivo correlation (IVIVC) studies can be used in the development of new pharmaceuticals to reduce the number of human studies during formulation development. The main objective of an IVIVC is to serve as a surrogate for in vivo bioavailability and to support biowaivers. IVIVCs could also be employed to establish dissolution specifications and to support and validate the use of dissolution methods. This is because the IVIVC includes in vivo relevance to in vitro dissolution