Clinical Endpoint Bioequivalence Studies Are Not Sensitive: A Perspective From Generic Drugs

被引：6

作者：

Novakovic, Jasmina ^{[1
]}

Szirtes, Julie ^{[1
]}

Fields, Anat ^{[1
]}

Tsang, Yu Chung ^{[1
]}

机构：

[1] Apotex Inc, Toronto, ON, Canada

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2019年 / 105卷 / 02期

关键词：

D O I：

10.1002/cpt.1244

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

For locally acting drugs (LADs) that exert their therapeutic effect directly at the site of action and are either minimally absorbed or their systemically absorbed portion does not reflect drug amount at the site of action, standard bioequivalence (BE) studies with pharmacokinetic (PK) end points(1) are not feasible or are inadequate for assuring equivalent therapeutic effects of generic and reference products. When surrogate end points (or biomarkers) are unavailable, clinical endpoint bioequivalence (CEBE) studies are recommended.(2-4)

引用

页码：295 / 297

页数：3

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