Biomarker qualification pilot process at the US food and drug administration

被引：95

作者：

Goodsaid, Federico ^{[1
]}

Frueh, Felix ^{[1
]}

机构：

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

来源：

AAPS JOURNAL | 2007年 / 9卷 / 01期

关键词：

biomarker; validation; FDA;

D O I：

10.1208/aapsj0901010

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

New biomarkers of safety and efficacy are becoming powerful tools in drug development. Their application can be accelerated if a consensus can be reached about their qualification for regulatory applications. This consensus requires a review structure within the US Food and Drug Administration (FDA) that can evaluate qualification data for these biomarkers and determine whether these biomarkers can be qualified. A pilot process and corresponding Biomarker Qualification Review Team have been developed to test how the FDA can work on biomarker qualification.

引用

页码：E105 / E108

页数：4