The Current State and Future Prospects of Population Pharmacokinetic Research in Post-marketing Clinical Studies in Japan-Reference-Cited by-同舟云学术

The Current State and Future Prospects of Population Pharmacokinetic Research in Post-marketing Clinical Studies in Japan

Published:2019-10-01 Issue:10 Volume:139 Page:1297-1303
ISSN:0031-6903
Container-title:YAKUGAKU ZASSHI
language:en
Short-container-title:YAKUGAKU ZASSHI

Author:

Watanabe-Uchida Megumi¹,Watanabe Tatsuya²,Narukawa Mamoru¹

Affiliation:

1. Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University

2. Kitasato Clinical Research Center, School of Medicine, Kitasato University

Publisher

Pharmaceutical Society of Japan

Subject

Pharmaceutical Science,Pharmacology

Link

https://www.jstage.jst.go.jp/article/yakushi/139/10/139_18-00227/_pdf

Reference22 articles.

1. 1) U.S. Department of Health and Human Services, Food and Drug Administration, FDA Guidance for Industry: Population pharmacokinetics, 1999.

2. 2) U.S. Department of Health and Human Services, Food and Drug Administration, FDA Guidance for Industry: Exposure-Response Relationships—Study Design, Data Analysis, and Regulatory Applications, 2003.

3. 3) Clinical Pharmacokinetic studies of pharmaceuticals: notification No. 796 issued by the Director of the Evaluation and Licensing Division, Pharmaceutical and Medical Safety Bureau, Ministry of Health and Welfare, 2001.

4. 4) Guidance on population pharmacokinetics and pharmacodynamics issued by the Evaluation and Licensing Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, 2019.

5. 5) Nakade S., Nakanishi M., Higuchi S., Jpn. J. Clin. Pharmacol. Ther., 34, 329-338 (2003).

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