Establishing consistency across all regions in a multi-regional clinical trial-Reference-Cited by-同舟云学术

Establishing consistency across all regions in a multi-regional clinical trial

Published:2012-04-16 Issue:4 Volume:11 Page:295-299
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceut. Statist.

Author:

Tsou Hsiao-Hui¹,James Hung H. M.²,Chen Yue-Ming¹,Huang Wong-Shian¹,Chang Wan-jung¹,Hsiao Chin-Fu

Affiliation:

1. Division of Biostatistics and Bioinformatics; Institute of Population Health Sciences, National Health Research Institutes; Zhunan Town; Miaoli County; Taiwan; ROC

2. Division of Biometrics I, DB1/OB/OTS/CDER; US Food and Drug Administration; Silver Spring; MD; USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference11 articles.

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2. Labour and welfare of Japan (MHLW);Ministry of Health;Basic Principles on Global Clinical Trials,2007

3. ICH International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Q&A for the ICH E5 guldeline on ethnic factors in the acceptability of foreign data 2006 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficay/ES_Rl/Q_As/E5_Q_As_RS_.pdf

4. An approach to rationalize partitioning sample size into individual regions in a multiregional trial;Kawai;Drug Information Journal,2008

5. Sample size considerations for Japanese patients in a multi-regional trial based on MHLW guidance;Quan;Pharmaceutical Statistics,2010

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