Ethnic differences in pharmacokinetics in new drug applications and approved doses in Japan

Journal of Clinical Pharmacology

Volumn 51, Issue 8, 2011, Pages 1237-1240

  Fukunaga, Satoshi ^a   Kusama, Makiko ^a   Arnold, Frank L ^a   Ono, Shunsuke ^a  

^a UNIVERSITY OF TOKYO   (Japan)

Author keywords

drug development; drug evaluation; ethnic differences; ICH E5 guideline; Pharmacokinetics

Indexed keywords

NEW DRUG;

AREA UNDER THE CURVE; ARTICLE; DRUG APPROVAL; ETHNIC DIFFERENCE; JAPAN; MAXIMUM PLASMA CONCENTRATION; PHARMACOKINETICS;

ASIAN CONTINENTAL ANCESTRY GROUP; BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INDUSTRY; DRUGS, INVESTIGATIONAL; EUROPEAN CONTINENTAL ANCESTRY GROUP; GUIDELINES AS TOPIC; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; JAPAN; PATIENT SELECTION; RESEARCH DESIGN; UNITED STATES;

EID: 79960708081     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010381500     Document Type: Article

References (8)

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