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
收藏
页码：467 / 470
页数：4
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