Points to Consider for Implementation of the ICH E17 Guideline: Learning from Past Multiregional Clinical Trials in Japan-Reference-Cited by-同舟云学术

Points to Consider for Implementation of the ICH E17 Guideline: Learning from Past Multiregional Clinical Trials in Japan

Author:

Asano Kunihito¹²,Aoi Yoko³,Kamada Shuji³,Uyama Yoshiaki⁴⁵,Tohkin Masahiro¹

Affiliation:

1. Department of Regulatory Science Graduate School of Pharmaceutical Sciences Nagoya City University Nagoya Japan

2. Office of New Drug III Pharmaceuticals and Medical Devices Agency (PMDA) Tokyo Japan

3. Office of New Drug V Pharmaceuticals and Medical Devices Agency (PMDA) Tokyo Japan

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

5. Department of Regulatory Science of Medicine Graduate School of Medicine Chiba University Chiba Japan

Funder

Japan Agency for Medical Research and Development

Ministry of Health, Labour and Welfare

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

Reference16 articles.

4. ICH E17 guideline: General principles for planning and design of multi‐regional clinical trials (final version)(2017). . Accessed July 17 2020.

5. Ministry of Health Labour and Welfare.Basic principles on global clinical trials(2007). . Accessed July 17 2020.

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