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

共 11 条

[1] GOODSAID F, UNPUB DRUG DISC TODA
[2] GOODSAID F, UNPUB DRUG DISCOV TO
[3] Implementing the US FDA Guidance on Pharmacogenomic Data Submissions
Goodsaid, Federico
Frueh, Felix W.
[J]. ENVIRONMENTAL AND MOLECULAR MUTAGENESIS, 2007, 48 (05) : 354 - 358
[4] Process map proposal for the validation of genomic biomarkers
Goodsaid, Federico
Frueh, Felix
[J]. PHARMACOGENOMICS, 2006, 7 (05) : 773 - 782
[5] Biomarker qualification pilot process at the US food and drug administration
Goodsaid, Federico
Frueh, Felix
[J]. AAPS JOURNAL, 2007, 9 (01) : E105 - E108
[6] Fit-for-purpose method development and validation for successful biomarker measurement
Lee, JW
Devanarayan, V
Barrett, YC
Weiner, R
Allinson, J
Fountain, S
Keller, S
Weinryb, I
Green, M
Duan, L
Rogers, JA
Millham, R
O'Brien, PJ
Sailstad, J
Khan, M
Ray, C
Wagner, JA
[J]. PHARMACEUTICAL RESEARCH, 2006, 23 (02) : 312 - 328
[7] Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: Criteria, validation, strategies
Lesko, LJ
Atkinson, AJ
[J]. ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY, 2001, 41 : 347 - 366
[8] ORR MS, 2007, EXPERIENCE VOLUNTARY
[9] The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): A review of the ICCVAM test method evaluation process and current international collaborations with the European Centre for the Validation of Alternative Methods (ECVAM)
Stokes, WS
Schechtman, LM
Hill, RN
[J]. ATLA-ALTERNATIVES TO LABORATORY ANIMALS, 2002, 30 : 23 - 32
[10] Stokes WS, 2006, ALTEX S, V23, P342

← 1 2 →