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The US food and drug administration perspective on cancer biomarker development

被引：140
作者：
Gutman, Steven
Kessler, Larry G.
机构：
[1] US FDA, Off In Vitro Diagnost Devices, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA
[2] US FDA, Off Sci, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA
[3] US FDA, Engn Labs, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA
来源：
NATURE REVIEWS CANCER | 2006年 / 6卷 / 07期
基金：
美国国家卫生研究院;
关键词：
D O I：
10.1038/nrc1911
中图分类号：
R73 [肿瘤学];
学科分类号：
100214 ;
摘要：
Despite the intense interest in biomarker development for cancer management, few biomarker assays for diagnostic uses have been submitted to the US Food and Drug Administration (FDA). What challenges must researchers overcome to bring cancer-detection technologies to the market and, therefore, into clinical use?
引用
收藏
页码：565 / 571
页数：8
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