A prototypical process for creating evidentiary standards for biomarkers and diagnostics

被引：45

作者：

Altar, C. A. ^{[10
]}

Amakye, D.

Bounos, D. ^{[1
]}

Bloom, J. ^{[2
]}

Clack, G. ^{[3
]}

Dean, R. ^{[2
]}

Devanarayan, V.

Fu, D. ^{[4
]}

Furlong, S. ^{[3
]}

Hinman, L. ^{[5
]}

Girman, C. ^{[6
]}

Lathia, C.

Lesko, L. ^{[7
]}

Madani, S. ^{[8
]}

Mayne, J.

Meyer, J. ^{[9
]}

Raunig, D. ^{[8
]}

Sager, P. ^{[3
]}

Williams, S. A.

Wong, P. ^{[5
]}

Zerba, K. ^{[11
]}

机构：

[1] Bristol Myers Squibb Co, Wallingford, CT 06492 USA

[2] Lilly, Indianapolis, IN USA

[3] Astra Zeneca, Wilmington, DE USA

[4] PhRMA, Washington, DC USA

[5] Novartis, Cambridge, MA USA

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

[7] US FDA, Washington, DC 20204 USA

[8] Novartis, Rockville, MD USA

[9] Pfizer, New London, CT USA

[10] Fdn Natl Inst Hlth, Washington, DC USA

[11] Bristol Myers Squibb Co, Princeton, NJ USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2008年 / 83卷 / 02期

关键词：

D O I：

10.1038/sj.clpt.6100451

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

A framework for developing evidentiary standards for qualification of biomarkers is a key need identified in the Food and Drug Administration's Critical Path Initiative. 1 This article describes a systematic framework that was developed by Pharmaceutical Research and Manufacturers of America (PhRMA) committees and tested at a workshop in collaboration with the Food and Drug Administration and academia. With some necessary refinements, this could be applied to create an appropriately individualized evidentiary standard for any biomarker purpose.

引用

页码：368 / 371

页数：4

共 4 条

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