Löbenberg R, Amidon G L
Faculty of Pharmacy and Pharmaceutical Science, Dentistry/Pharmacy Centre, University of Alberta, Alberta, Edmonton, Canada.
Eur J Pharm Biopharm. 2000 Jul;50(1):3-12. doi: 10.1016/s0939-6411(00)00091-6.
In the last decade, the regulatory bioequivalence (BE) requirements of drug products have undergone major changes. The introduction of the biopharmaceutics drug classification system (BCS) into the guidelines of the Food and Drug Administration (FDA) is a major step forward to classify the biopharmaceutical properties of drugs and drug products. Based on mechanistic approaches to the drug absorption and dissolution processes, the BCS enables the regulatory bodies to simplify and improve the drug approval process. The knowledge of the BCS characteristics of a drug in a formulation can also be utilized by the formulation scientist to develop a more optimized dosage form based on fundamental mechanistic, rather than empirical, information. This report gives a brief overview of the BCS and its implications.
在过去十年中，药品的监管生物等效性（BE）要求发生了重大变化。将生物药剂学分类系统（BCS）引入美国食品药品监督管理局（FDA）的指南是对药物和药品的生物药剂学特性进行分类的重要一步。基于药物吸收和溶解过程的机制方法，BCS使监管机构能够简化和改进药物审批过程。制剂科学家也可以利用制剂中药物的BCS特性知识，根据基本的机制信息而非经验信息来开发更优化的剂型。本报告简要概述了BCS及其影响。
