Is this the drug or dose for you? Impact and consideration of ethnic factors in global drug development, regulatory review, and clinical practice

被引：117

作者：

Huang, S-M ^{[1
]}

Temple, R. ^{[2
]}

机构：

[1] US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[2] US FDA, Off Med Policy, Ctr Drug Evaluat & Res, Silver Spring, MD USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2008年 / 84卷 / 03期

关键词：

D O I：

10.1038/clpt.2008.144

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

引用

页码：287 / 294

页数：8

共 24 条

[1] AMUR S, BIOMARKERS MED, V2, P305
[2] [Anonymous], 1998, Computerized Support Enforcement Systems
[3] *BRITS MEYERS SQUI, COUM LAB
[4] Medical product development and regulatory science for the 21st century: The critical path vision and its impact on health care
Buckman, S.
Huang, S-M
Murphy, S.
[J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2007, 81 (02) : 141 - 144
[5] Genetic Variation in Drug Transporters in Ethnic Populations (vol 84, pg, 412, 2008)
Cropp, C. D.
Yee, S. W.
Giacomini, K. M.
[J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2009, 85 (01) : 108 - 109
[6] Use of pharmacogenetic and clinical factors to predict the therapeutic dose of warfarin
Gage, B. F.
Eby, C.
Johnson, J. A.
Deych, E.
Rieder, M. J.
Ridker, P. M.
Milligan, P. E.
Grice, G.
Lenzini, P.
Rettie, A. E.
Aquilante, C. L.
Grosso, L.
Marsh, S.
Langaee, T.
Farnett, L. E.
Voora, D.
Veenstra, D. L.
Glynn, R. J.
Barrett, A.
McLeod, H. L.
[J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2008, 84 (03) : 326 - 331
[7] Warfarin and pharmacogenomic testing: The case for restraint
Garcia, D. A.
[J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2008, 84 (03) : 303 - 305
[8] Drug interaction studies: Study design, data analysis, and implications for dosing and labeling
Huang, S-M
Temple, R.
Throckmorton, D. C.
Lesko, L. J.
[J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2007, 81 (02) : 298 - 304
[9] The critical path of warfarin dosing: Finding an optimal dosing strategy using pharmacogenetics
Lesko, L. J.
[J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2008, 84 (03) : 301 - 303
[10] Li JS, 2008, CLIN PHARMACOL THER, V84, P315, DOI 10.1038/clpt.2008.113

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