The importance of a regulatory science approach for better pharmaceutical regulation-Reference-Cited by-同舟云学术

The importance of a regulatory science approach for better pharmaceutical regulation

Published:2019 Issue:1 Volume:1 Page:8-11
ISSN:2434-4974
Container-title:Translational and Regulatory Sciences
language:en
Short-container-title:

Author:

Uyama Yoshiaki¹

Affiliation:

1. Office of Medical Informatics and Epidmeiology, Pharmaceuticals & Medical Devices Agency (PMDA), Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan

Publisher

AMED iD3 Catalyst Unit

Link

https://www.jstage.jst.go.jp/article/trs/1/1/1_1907/_pdf

Reference13 articles.

1. 1. Tominaga T., Asahina Y., Uyama Y. and Kondo T. 2011. Regulatory science as a bridge between science and society. Clin. Pharmacol. Ther. 90: 29–31.

2. 2. Hamburg M. A. 2011. Advancing regulatory science. Science 331: 987.

3. 3. Ramamoorthy A., Pacanowski M. A., Bull J. and Zhang L. 2015. Racial/ethnic differences in drug disposition and response: review of recently approved drugs. Clin. Pharmacol. Ther. 97: 263–273.

4. 4. Yasuda S. U., Zhang L. and Huang S. M. 2008. The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies. Clin. Pharmacol. Ther. 84: 417–423.

5. 5. Ichimaru K., Toyoshima S. and Uyama Y. 2010. Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors. Clin. Pharmacol. Ther. 87: 362–366.

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