Applications of PBPK Modeling and Simulations in The Clinical Pharmacology Field: Lessons from Several Case Studies-Reference-Cited by-同舟云学术

Applications of PBPK Modeling and Simulations in The Clinical Pharmacology Field: Lessons from Several Case Studies

Published:2020-11-30 Issue:6 Volume:51 Page:331-344
ISSN:0388-1601
Container-title:Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
language:en
Short-container-title:Jpn. J. Clin. Pharmacol. Ther.

Author:

EMOTO Chie¹²,DOKI Kosuke³,MATSUMOTO Yuki⁴,KIJIMA Shinichi⁵,NAKAMURA Mikiko⁶,FUKUDA Tsuyoshi²⁷

Affiliation:

1. Division of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, USA

2. Laboratory of Drug Metabolism and Pharmacokinetics, Showa Pharmaceutical University, Japan

3. Department of Pharmaceutical Sciences, Faculty of Medicine, University of Tsukuba, Japan

4. Clinical Pharmacokinetics & Pharmacometrics Group, Clinical Pharmacology Development, Clinical Research, Japan Development, MSD K. K., Japan

5. Pharmaceuticals and Medical Devices Agency (PMDA), Japan

6. Pharmacometrics Group, Clinical Pharmacology Dept., Chugai Pharmaceutical Co., LTD., Japan

7. National Center for Child Health and Development, Japan

Publisher

Japanese Society of Clinical Pharmacology and Therapeutics

Subject

Pharmacology (medical),Pharmacology

Link

https://www.jstage.jst.go.jp/article/jscpt/51/6/51_331/_pdf

Reference48 articles.

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2. 2) U.S. Department of Health and Human Services - Food and Drug Administration; CDER. Guidance for Industry―Physiologically Based Pharmacokinetic Analyses―Format and Content. August 2018.

3. 4) Klintmalm GB. Immunosuppression, generic drugs and the FDA. Am J Transplant. 2011; 11(9) : 1765-6. doi: 10.1111/j.1600-6143.2011.03616.x.

4. 5) Doki K, Darwich AS, Patel N, Rostami-Hodjegan A. Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria. Eur J Pharm Sci. 2017; 109: 111-20. doi: 10.1016/j.ejps.2017.07.035.

5. 6) Morihara M, Aoyagi N, Kaniwa N, Kojima S, Ogata H. Assessment of gastric acidity of Japanese subjects over the last 15 years. Biol Pharm Bull. 2001; 24(3): 313-5. doi: 10.1248/bpb.24.313.