title: Commonality between BCS and TCS.
abstract: Both biopharmaceutics classification system (BCS) and topical drug classification system (TCS) are based on sound scientific principles with the aim of providing biowaiver and reducing regulatory burden without lowering the quality requirements and standards of approval for the drug products. BCS is based on the solubility and permeability properties of the active pharmaceutical ingredient (API, or drug substance) whereas the TCS is based on the qualitative and quantitative composition of the dosage form and the in vitro release rate of the active ingredient as key decision tools. Both BCS and TCS take drug release and dissolution as their guiding principle for providing biowaiver, increasing the availability and affordability of safe and effective medicines to the consumers and at the same time maintaining the drug product quality.
authors.affiliation: Pharmaceutical Consultant, North Potomac, MD, USA. Electronic address: dr.vpshah@comcast.net.
authors.forename: Vinod P
authors.initials: VP
authors.lastname: Shah
authors.affiliation: Department of Drug Industry and Pharmaceutical Biotechnologies, Faculty of Pharmacy, University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania.
authors.forename: Flavian Ştefan
authors.initials: FŞ
authors.lastname: Rădulescu
authors.affiliation: Department of Pharmaceutical Physics and Informatics, Faculty of Pharmacy, University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania.
authors.forename: Dalia Simona
authors.initials: DS
authors.lastname: Miron
authors.affiliation: DOLE Pharma LLC, Englewood, NJ, USA.
authors.forename: Avraham
authors.initials: A
authors.lastname: Yacobi
mesh_terms: D001682:Biological Availability; D001702:Biopharmaceutics / Q000379:methods; D002626:Chemistry, Pharmaceutical / Q000379:methods; D065546:Drug Liberation; D005079:Excipients / Q000737:chemistry; D006801:Humans; D010539:Permeability; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012995:Solubility; D013810:Therapeutic Equivalency
chemical_list: D005079:Excipients; D004364:Pharmaceutical Preparations
keywords: BCS; Biowaiver; In vitro release; TCS; Topical drug classification system