Decision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multiregional Clinical Trials-Reference-Cited by-同舟云学术

Decision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multiregional Clinical Trials

Published:2012-09-01 Issue:5 Volume:22 Page:1001-1018
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Chen Xiaoyuan¹²,Lu Nelson³,Nair Rajesh³,Xu Yunling³,Kang Cailian²,Huang Qin²,Li Ning⁴,Chen Hongzhuan¹

Affiliation:

1. a Department of Pharmacology and Biostatistics , Shanghai JiaoTong University School of Medicine , Shanghai , China

2. c Center for Drug Evaluation, China State Food and Drug Administration , Beijing , China

3. b Office of Surveillance and Biometrics , CDRH, U.S. Food and Drug Administration , Silver Spring , Maryland , USA

4. d U.S. Food and Drug Administration Alumni Association , Gaithersburg , Maryland , USA

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2012.701582

Reference8 articles.

1. European Medicines Agency. ( 2009 ). Reflection Paper on the Extrapolation of Results From Clinical Studies Conducted Outside Europe to the EU Population. EMEA. Available at: www.emea.europa.eu/pdfs/human/ewp/69270208en.pdf (accessed May 25, 2012) .

2. Ethical and Scientific Implications of the Globalization of Clinical Research

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

4. Sample Size Determination for a Specific Region in a Multiregional Trial

5. Ministry of Health , Labor , and Welfare of Japan. ( 2007 ). Basic Principles on Global Clinical Trials. Tokyo: MHLW .

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