Strategic paths for biomarker qualification

被引：61

作者：

Goodsaid, Federico M. ^{[1
]}

Frueh, Felix W. ^{[1
]}

Mattes, William

机构：

[1] US FDA, Ctr Drug Evaluat & Res, Off Translat Sci, Off Clin Pharmacol,Genom Grp, Silver Spring, MD 20903 USA

来源：

TOXICOLOGY | 2008年 / 245卷 / 03期

关键词：

biomarkers; consortia;

D O I：

10.1016/j.tox.2007.12.023

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Biomarkers may be qualified using different qualification processes. A passive approach for qualification has been to accept the end of discussions in the scientific literature as an indication that a biomarker has been accepted. An active approach to qualification requires development of a comprehensive process by which a consensus may be reached about the qualification of a biomarker. Active strategies for qualification include those associated with context-independent as well as context-dependent qualifications. (C) 2007 Elsevier Ireland Ltd. All rights reserved.

引用

页码：219 / 223

页数：5

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