The FDA Should Eliminate the Ambiguities in the Current BCS Biowaiver Guidance and Make Public the Drugs for Which BCS Biowaivers Have Been Granted

被引：26

作者：

Benet, L. Z. ^{[1
,2
]}

Larregieu, C. A. ^{[1
,2
]}

机构：

[1] Univ Calif San Francisco, Sch Pharm, Dept Bioengn & Therapeut Sci, San Francisco, CA 94143 USA

[2] Univ Calif San Francisco, Sch Med, Dept Bioengn & Therapeut Sci, San Francisco, CA 94143 USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2010年 / 88卷 / 03期

关键词：

INTESTINAL PERMEABILITY; CLASSIFICATION;

D O I：

10.1038/clpt.2010.149

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Although US Food and Drug Administration (FDA)-approved Biopharmaceutics Classification System (BCS) class 1 drugs are designated as high-permeability drugs, in fact, the criterion utilized is high extent of absorption. This ambiguity should be eliminated, and the FDA criterion should explicitly be stated as >= 90% absorption based on absolute bioavailability or mass balance. Maintaining confidentiality regarding the drugs for which the FDA has approved BCS waivers of in vivo bioequivalence studies is not good public policy and should be reversed.

引用

页码：405 / 407

页数：3

共 11 条

[1] A THEORETICAL BASIS FOR A BIOPHARMACEUTIC DRUG CLASSIFICATION - THE CORRELATION OF IN-VITRO DRUG PRODUCT DISSOLUTION AND IN-VIVO BIOAVAILABILITY [J].