Comparison of Successful and Unsuccessful Cases of New Drug Approvals Based on the International Council on Harmonization E5 Guidelines in Japan-Reference-Cited by-同舟云学术

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Comparison of Successful and Unsuccessful Cases of New Drug Approvals Based on the International Council on Harmonization E5 Guidelines in Japan

Published:2021-03-30 Issue:5 Volume:10 Page:434-439
ISSN:2160-763X
Container-title:Clinical Pharmacology in Drug Development
language:en
Short-container-title:Clinical Pharmacology in Drug Development

Author:

Asada Ryuta¹,Shimizu Shinobu²,Nakamura Harumasa³,Ono Shunsuke⁴,Yamaguchi Takuhiro⁵

Affiliation:

1. Innovative and Clinical Research Promotion Center Gifu University Hospital Gifu Japan

2. Department of Advanced Medicine Nagoya University Hospital Nagoya Japan

3. Translational Medical Center National Center of Neurology and Psychiatry Tokyo Japan

4. Laboratory of Pharmaceutical Regulatory Science Graduate School of Pharmaceutical Sciences University of Tokyo Tokyo Japan

5. Department of Biostatistics Tohoku University Graduate School of Medicine Sendai Japan

Publisher

Wiley

Subject

Pharmacology (medical),Pharmaceutical Science

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpdd.942

Reference20 articles.

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

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

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

4. Significant Differences in Drug Lag in Clinical Development Among Various Strategies Used for Regulatory Submissions in Japan

5. Bridging studies in Japan and Taiwan: a dynamic evolution in regulating ethnic differences;Kuo W;Ther Innov Regul Sci,2009

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