title: G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability, Pharm Res 12, 413-420, 1995--backstory of BCS.
abstract: The Biopharmaceutics Classification System (BCS) has become widely accepted today in the academic, industrial, and regulatory world. While the initial application of the BCS was to regulatory science bioequivalence (BE) issues and related implications, it has come to be utilized widely by the pharmaceutical industry in drug discovery and development as well. This brief manuscript will relate the story of the BCS development. While much of the ground work for the BCS goes back to the pharmacokinetic and drug absorption research by Gordon Amidon (GLA) in the 1970s and 1980s, the realization of the need for a classification or categorization of drug and drug products for setting dissolution standards became apparent to GLA during his 1990-1991 sabbatical year at the FDA. Initiated at the invitation of the then CEDR director, Dr. Carl Peck, to become a visiting scientist at the FDA, the goal was to promote regulatory research at the FDA, in my case, in biopharmaceutics, and to develop a science-based system to simplify regulatory requirements.
authors: Pharmaceutical Consultant, North Potomac, Maryland, 20878, USA.
authors: Vinod P
authors: VP
authors: Shah
authors: Gordon L
authors: GL
authors: Amidon
mesh_terms: D000818:Animals; D001682:Biological Availability; D001702:Biopharmaceutics / Q000145:classification* / Q000266:history; D004333:Drug Administration Routes; D017277:Drug Approval; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D008954:Models, Biological; D008956:Models, Chemical; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000145:classification* / Q000266:history / Q000378:metabolism; D010599:Pharmacokinetics; D012995:Solubility; D009626:Terminology as Topic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations