Bioequivalence of Oral Products and the Biopharmaceutics Classification System: Science, Regulation, and Public Policy

被引：36

作者：

Amidon, K. S. ^{[2
]}

Langguth, P. ^{[3
]}

Lennernas, H. ^{[4
]}

Yu, L. ^{[5
]}

Amidon, G. L. ^{[1
]}

机构：

[1] Univ Michigan, Coll Pharm, Ann Arbor, MI 48109 USA

[2] Iowa State Univ, Dept World Languages & Cultures, Ames, IA USA

[3] Johannes Gutenberg Univ Mainz, Dept Biopharm & Pharmaceut Technol, Mainz, Germany

[4] Uppsala Univ, Dept Pharm, Uppsala, Sweden

[5] US FDA, Off Gener Drugs, Rockville, MD 20857 USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2011年 / 90卷 / 03期

关键词：

INTESTINAL PERMEABILITY; UNITED-STATES; DRUG; CACO-2; BCS; FDA;

D O I：

10.1038/clpt.2011.109

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：467 / 470

页数：4

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