Biornarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs

被引：134

作者：

Wagner, J. A. ^{[1
]}

Williams, S. A.

Webster, C. J.

机构：

[1] Merck & Co Inc, Rahway, NJ 07065 USA

[2] Pfizer Global Res & Dev, New London, CT USA

[3] Millennium Pharmaceut Inc, Cambridge, MA USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2007年 / 81卷 / 01期

关键词：

D O I：

10.1038/sj.clpt.6100017

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

A consistent framework for the acceptance and qualification of biomarkers for regulatory use is needed to facilitate innovative and efficient research and subsequent application of biomarkers in drug development. One key activity is biomarker qualification, a graded, "fit-for-purpose" evidentiary process linking a biomarker with biology and clinical end points. A biomarker consortium model win distribute cost and risk, and drive efficient execution of research and ultimately regulatory acceptance of biomarkers for specific indications.

引用

页码：104 / 107

页数：4

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