Bioequivalence of Oral Products and the Biopharmaceutics Classification System: Science, Regulation, and Public Policy
Date
2011-09-01
Authors
Amidon, Kevin
Langguth, P.
Lennernas, H.
Yu, L.
Amidon, G.L.
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World Languages and Cultures
The Department of World Languages and Cultures seeks to provide an understanding of other cultures through their languages, providing both linguistic proficiency and cultural literacy. Majors in French, German, and Spanish are offered, and other coursework is offered in Arabic, Chinese, Classical Greek, Latin, Portuguese, and Russian
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World Languages and Cultures
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.
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This article is from Clinical Pharmacology & Therapeutics 90 (2011): 467, doi:10.1038/clpt.2011.109. Posted with permission.