Current Status and Open Issues Concerning Global Clinical Trials (GCTs) in Japan and East Asia-Reference-Cited by-同舟云学术

Current Status and Open Issues Concerning Global Clinical Trials (GCTs) in Japan and East Asia

Published:2017-07-04 Issue:6 Volume:10 Page:503-508
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clinical And Translational Science

Author:

Miyazaki Koichi¹²,Sato Yasunori³,Hanaoka Hideki²³,Uyama Yoshiaki²⁴

Affiliation:

1. Asia Development DepartmentDaiichi Sankyo Co. Ltd. Tokyo Japan

2. Department of Regulatory Science of MedicineGraduate School of Medicine, Chiba University Chiba Japan

3. Division of Clinical Research CenterChiba University Hospital Chiba Japan

4. Office of Medical Informatics and EpidemiologyPharmaceuticals and Medical Devices Agency (PMDA) Tokyo Japan

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/cts.12485

Reference18 articles.

1. Regulatory Challenges in the Review of Data from Global Clinical Trials: The PMDA Perspective

2. Ministry of Health Labour and Welfare.Basic principles on global clinical trials. Notification 0928010 (28 September 2007).http://www.pmda.go.jp/files/000153265.pdfAccessed February 12 2017.

3. Ministry of Health Labour and Welfare.Basic Principles on Global Clinical Trials (Reference Cases). Administrative Notice (5 September 2012).http://www.nihs.go.jp/mss/Kokusaikyodo-2.pdf. Accessed February 12 2017.

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

5. Regulatory and Scientific Issues Regarding Use of Foreign Data in Support of New Drug Applications in the United States: An FDA Perspective

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