Consideration of regional difference in design and analysis of multi-regional trials

Author:

Hung H. M. James,Wang Sue-Jane,O'Neill Robert T.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference13 articles.

1. Ethnic factor in the acceptability of foreign data;ICH International Conference on Harmonization Tripartite Guidance E5;The US Federal Register,1998

2. Ministry of Health, Labor and Welfare of Japan 2007

3. An approach to rationalize partitioning sample size into individual regions in a multiregional trial;Kawai;Drug Information Journal,2007

4. Sekiguchi R Ogawa S Uesaka H Sample size determination of Japanese patients for multi-regional clinical trial (MRCT) in oncology

5. Sample size considerations for Japanese patients in a multi-regional trial based on MHLW guidance;Quan;Pharmaceutical Statistics,2009

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