Sample size considerations for Japanese patients in a multi-regional trial based on MHLW guidance

Pharmaceutical Statistics

Volumn 9, Issue 2, 2010, Pages 100-112

  Quan, Hui ^a   Zhao, Peng Liang ^a   Zhang, Ji ^a   Roessner, Martin ^a   Aizawa, Kyo ^a  

^a SANOFI   (France)

Author keywords

Bridging study; Delta method; Ethnic effect; Risk reduction; Survival endpoint

Indexed keywords

ARTICLE; HAZARD ASSESSMENT; HUMAN; JAPANESE; SAMPLE SIZE; SIMULATION; SURVIVAL; ASIAN CONTINENTAL ANCESTRY GROUP; CLINICAL TRIAL (TOPIC); COMPUTER SIMULATION; DRUG APPROVAL; MULTICENTER STUDY (TOPIC); PRACTICE GUIDELINE; PROCEDURES; STATISTICAL MODEL; STATISTICS AND NUMERICAL DATA; SURVIVAL ANALYSIS;

ASIAN CONTINENTAL ANCESTRY GROUP; CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; DRUG APPROVAL; GUIDELINES AS TOPIC; HUMANS; MODELS, STATISTICAL; MULTICENTER STUDIES AS TOPIC; SAMPLE SIZE; SURVIVAL ANALYSIS;

EID: 77954634717     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.380     Document Type: Article

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