Pharmacogenomic data: FDA voluntary and required submission guidance

被引：28

作者：

Salerno, RA ^{[1
]}

Lesko, LJ ^{[1
]}

机构：

[1] Wyeth Res, Worldwide Regulatory Affairs, Collegeville, PA 19426 USA

来源：

PHARMACOGENOMICS | 2004年 / 5卷 / 05期

关键词：

D O I：

10.1517/14622416.5.5.503

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

[No abstract available]

引用

页码：503 / 505

页数：3

共 5 条

[1] Pharmacogenomic data submissions to the FDA: non-clinical case studies [J].

Leighton, JK ;

DeGeorge, J ;

Jacobson-Kram, D ;

MacGregor, J ;

Mendrick, D ;

Worobec, A .

PHARMACOGENOMICS, 2004, 5 (05) :507-511

[2] Pharmacogenomic data submissions to the FDA:: clinical pharmacology case studies [J].

Ruaño, G ;

Collins, JM ;

Dorner, AJ ;

Wang, SJ ;

Guerciolini, R ;

Huang, SM .

PHARMACOGENOMICS, 2004, 5 (05) :513-517

[3]

Salerno RA, 2004, PHARMACOGENOMICS, V5, P25

[4] Pharmacogenomic data submissions to the FDA: clinical case studies [J].

Trepicchio, WL ;

Williams, GA ;

Essayan, D ;

Hall, ST ;

Harty, LC ;

Shaw, PM ;

Spear, BB ;

Wang, SJ ;

Watson, ML .

PHARMACOGENOMICS, 2004, 5 (05) :519-524

[5]

2003, FED REG, V68, P62461

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