Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications

被引：0
作者：
Barbara M. Davit
Dale P. Conner
Beth Fabian-Fritsch
Sam H. Haidar
Xiaojian Jiang
Devvrat T. Patel
Paul R. H. Seo
Keri Suh
Christina L. Thompson
Lawrence X. Yu
机构：
[1] Center for Drug Evaluation and Research,U.S. Food and Drug Administration
[2] Office of Generic Drugs,undefined
来源：
The AAPS Journal | 2008年 / 10卷
关键词：
bioequivalence; generic drugs; highly variable drugs; presystemic drug metabolism; variable drug product dissolution;
D O I：
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摘要：
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页码：148 / 156
页数：8
相关论文
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