口服制剂的生物等效性与生物药剂学分类系统：科学、法规与公共政策。
Bioequivalence of oral products and the biopharmaceutics classification system: science, regulation, and public policy.
机构信息
Department of World Languages and Cultures, Iowa State University, Ames, Iowa, USA.
出版信息
Clin Pharmacol Ther. 2011 Sep;90(3):467-70. doi: 10.1038/clpt.2011.109. Epub 2011 Jul 20.
Abstract
The demonstration of bioequivalence (BE) is an essential requirement for ensuring that patients receive a product that performs as indicated by the label. The BE standard for a particular product is set by its innovator, and this standard must subsequently be matched by generic drug products. The Biopharmaceutics Classification System (BCS) sets a scientific basis for an improved BE standard for immediate-release solid oral dosage forms. In this paper, we discuss BE and the BCS, as well as the issues that are currently relevant to BE as a pharmaceutical product standard.
摘要
证明生物等效性 (BE) 是确保患者获得与标签所示性能一致的产品的必要要求。特定产品的 BE 标准由其创新者设定，随后必须由仿制药产品匹配。生物药剂学分类系统 (BCS) 为改进即时释放固体口服剂型的 BE 标准提供了科学依据。本文讨论了 BE 和 BCS，以及作为药品标准的 BE 目前相关的问题。
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