Multiregional Clinical Trials: Japanese Perspective on Drug Development Strategy and Sample Size for Japanese Subjects-Reference-Cited by-同舟云学术

Multiregional Clinical Trials: Japanese Perspective on Drug Development Strategy and Sample Size for Japanese Subjects

Published:2012-09-01 Issue:5 Volume:22 Page:977-987
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Ando Yuki¹,Uyama Yoshiaki²³

Affiliation:

1. a Biostatistics Group , Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency , Tokyo , Japan

2. b Division of Regulatory Science Research , Office of Regulatory Science Pharmaceuticals and Medical Devices Agency , Tokyo , Japan

3. c Department of Regulatory Science and Public Administration of Medicine, Graduate School of Medicine , Chiba University , Chiba , Japan

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2012.701581

Reference8 articles.

1. Practical issues and lessons learned from multi-regional clinical trials via case examples: a Japanese perspective

2. Exploring Differences in Drug Doses Between Japan and Western Countries

3. Effective Global Drug Development Strategy for Obtaining Regulatory Approval in Japan in the Context of Ethnicity-Related Drug Response Factors

4. Same Drug, Different Dosing: Differences in Dosing for Drugs Approved in the United States, Europe, and Japan

5. Ministry of Health, Labour and Welfare . ( 2007 ). Basic Principles on Global Clinical Trials. Notification No. 0928010, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan .

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