Pharmaceutical Consultant, North Potomac, MD, USA.
Department of Drug Industry and Pharmaceutical Biotechnologies, Faculty of Pharmacy, University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania.
Int J Pharm. 2016 Jul 25;509(1-2):35-40. doi: 10.1016/j.ijpharm.2016.05.032. Epub 2016 May 18.
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.
生物药剂学分类系统（BCS）和局部药物分类系统（TCS）都是基于可靠的科学原理，旨在提供生物豁免并减轻监管负担，同时不降低药品的质量要求和批准标准。BCS 基于活性药物成分（API 或药物物质）的溶解度和渗透性特性，而 TCS 则基于剂型的定性和定量组成以及活性成分的体外释放率作为关键决策工具。BCS 和 TCS 都以药物释放和溶解为指导原则，提供生物豁免，增加安全有效的药物对消费者的可及性和可负担性，同时保持药物产品的质量。
