Multiregional clinical trials: Japanese perspective on drug development strategy and sample size for Japanese subjects

Journal of Biopharmaceutical Statistics

Volumn 22, Issue 5, 2012, Pages 977-987

  Ando, Yuki ^a   Uyama, Yoshiaki ^a,b  

^a PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

^b CHIBA UNIVERSITY   (Japan)

Author keywords

Dose response; Ethnic factor; Multiregional clinical trial; Sample size

Indexed keywords

DABIGATRAN; DASATINIB; EDOXABAN; EVEROLIMUS; INDACATEROL; INSULIN GLULISINE; LANINAMIVIR; LINAGLIPTIN; LOSARTAN; NILOTINIB; PANITUMUMAB; PERAMIVIR; PRAMIPEXOLE; TADALAFIL; TEMSIROLIMUS; TIMOLOL PLUS TRAVOPROST; TOLTERODINE; TRASTUZUMAB;

ARTICLE; BREAST CANCER; CHRONIC BRONCHITIS; CHRONIC MYELOID LEUKEMIA; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL EVALUATION; CLINICAL TRIAL (TOPIC); COLORECTAL CARCINOMA; DIABETES MELLITUS; DIABETIC NEPHROPATHY; DOCUMENTATION; DRUG APPROVAL; DRUG DESIGN; DRUG EFFICACY; DRUG MANUFACTURE; EMBOLISM; EMPHYSEMA; ETHNIC DIFFERENCE; GLAUCOMA; HEART ATRIUM FIBRILLATION; HUMAN; HYPERTENSION; INFLUENZA A; INFLUENZA B; JAPAN; JAPANESE; KIDNEY CARCINOMA; MULTICENTER STUDY (TOPIC); MULTIREGIONAL CLINICAL TRIAL; NON INSULIN DEPENDENT DIABETES MELLITUS; OVERACTIVE BLADDER; PARKINSON DISEASE; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROTEINURIA; PULMONARY HYPERTENSION; RISK FACTOR; SAMPLE SIZE; STOMACH CANCER; STROKE; SYSTEMIC EMBOLISM; TREND STUDY; URGE INCONTINENCE; VENOUS THROMBOEMBOLISM;

DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG APPROVAL; ETHNIC GROUPS; GUIDELINES AS TOPIC; HUMANS; JAPAN; MULTICENTER STUDIES AS TOPIC; RESEARCH DESIGN; RESEARCH SUBJECTS; SAMPLE SIZE;

EID: 84866293681     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2012.701581     Document Type: Article

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