Pharmacogenomic data submissions to the FDA:: clinical pharmacology case studies

被引：14

作者：

Ruaño, G

Collins, JM

Dorner, AJ

Wang, SJ

Guerciolini, R

Huang, SM ^{[1
]}

机构：

[1] Genomas LLC, New Haven, CT USA

[2] George Washington Univ, Dept Biochem & Mol Biol, Washington, DC USA

[3] Ctr Drug Evaluat & Res, Off Clin Pharmacol & Biopharmaceut, Rockville, MD 20850 USA

来源：

PHARMACOGENOMICS | 2004年 / 5卷 / 05期

关键词：

clinical pharmacology; DNA variants; gene expression; genomic data submission; microarray; pharmacogenetics; pharmacogenomics;

D O I：

10.1517/14622416.5.5.513

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

[No abstract available]

引用

页码：513 / 517

页数：5

共 4 条

[1] Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: Report of the first FDA-PWG-PhRMA-DruSafe workshop [J].

Lesko, LJ ;

Salerno, RA ;

Spear, BB ;

Anderson, DC ;

Anderson, T ;

Brazell, C ;

Collins, J ;

Dorner, A ;

Essayan, D ;

Gomez-Mancilla, B ;

Hackett, J ;

Huang, SM ;

Ide, S ;

Killinger, J ;

Leighton, J ;

Mansfield, E ;

Meyer, R ;

Ryan, SG ;

Schmith, V ;

Shaw, P ;

Sistare, F ;

Watson, M ;

Worobec, A .

JOURNAL OF CLINICAL PHARMACOLOGY, 2003, 43 (04) :342-358

[2] Pharmacogenomic data: FDA voluntary and required submission guidance [J].

Salerno, RA ;

Lesko, LJ .

PHARMACOGENOMICS, 2004, 5 (05) :503-505

[3]

Salerno RA, 2004, PHARMACOGENOMICS, V5, P25

[4]

2003, FED REG, V68, P62461

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