Ethnic Differences in Pharmacokinetics in New Drug Applications and Approved Doses in Japan

被引:20
作者
Fukunaga, Satoshi [1 ]
Kusama, Makiko [1 ]
Arnold, Frank L. [1 ]
Ono, Shunsuke [1 ]
机构
[1] Univ Tokyo, Grad Sch Pharmaceut Sci, Lab Pharmaceut Regulatory Sci, Bunkyo Ku, Tokyo 1130033, Japan
关键词
Pharmacokinetics; ethnic differences; drug evaluation; drug development; ICH-E5; guideline;
D O I
10.1177/0091270010381500
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
[No abstract available]
引用
收藏
页码:1237 / 1240
页数:4
相关论文
共 8 条
[1]   Exploring Differences in Drug Doses Between Japan and Western Countries [J].
Arnold, F. L. ;
Kusama, M. ;
Ono, S. .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2010, 87 (06) :714-720
[2]  
Balant LP, 2000, INT J CLIN PHARM TH, V38, P47
[3]   The importance of race and ethnic background in biomedical research and clinical practice [J].
Burchard, EG ;
Ziv, E ;
Coyle, N ;
Gomez, SL ;
Tang, H ;
Karter, AJ ;
Mountain, JL ;
Pérez-Stable, EJ ;
Sheppard, D ;
Risch, N .
NEW ENGLAND JOURNAL OF MEDICINE, 2003, 348 (12) :1170-1175
[4]   Ethnic or racial differences revisited - Impact of dosage regimen and dosage form on pharmacokinetics and pharmacodynamics [J].
Chen, Mei-Ling .
CLINICAL PHARMACOKINETICS, 2006, 45 (10) :957-964
[5]   Same drug, different dosing: Differences in dosing for drugs approved in the United States, Europe, and Japan [J].
Malinowski, Henry J. ;
Westelinck, Agnes ;
Sato, Junko ;
Ong, Ting .
JOURNAL OF CLINICAL PHARMACOLOGY, 2008, 48 (08) :900-908
[6]  
*MIN HLTH LAB WELF, 2007, NOT BAS PRINC GLOB C
[7]  
*MIN HLTH WELF JAP, 1998, ETHN FACT ACC FOR CL
[8]   Pharmacokinetics/genotype associations for major cytochrome P450 enzymes in native and first- and third-generation Japanese populations: Comparison with Korean, Chinese, and Caucasian populations [J].
Myrand, S. P. ;
Sekiguchi, K. ;
Man, M. Z. ;
Lin, X. ;
Tzeng, R-Y ;
Teng, C-H ;
Hee, B. ;
Garrett, M. ;
Kikkawa, H. ;
Lin, C-Y ;
Eddy, S. M. ;
Dostalik, J. ;
Mount, J. ;
Azuma, J. ;
Fujio, Y. ;
Jang, I-J ;
Shin, S-G ;
Bleavins, M. R. ;
Williams, J. A. ;
Paulauskis, J. D. ;
Wilner, K. D. .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2008, 84 (03) :347-361