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

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  • EMOTO Chie
    Division of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, USA Laboratory of Drug Metabolism and Pharmacokinetics, Showa Pharmaceutical University, Japan
  • DOKI Kosuke
    Department of Pharmaceutical Sciences, Faculty of Medicine, University of Tsukuba, Japan
  • MATSUMOTO Yuki
    Clinical Pharmacokinetics & Pharmacometrics Group, Clinical Pharmacology Development, Clinical Research, Japan Development, MSD K. K., Japan
  • KIJIMA Shinichi
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • NAKAMURA Mikiko
    Pharmacometrics Group, Clinical Pharmacology Dept., Chugai Pharmaceutical Co., LTD., Japan
  • FUKUDA Tsuyoshi
    Laboratory of Drug Metabolism and Pharmacokinetics, Showa Pharmaceutical University, Japan National Center for Child Health and Development, Japan

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  • 臨床薬理分野での PBPK モデルの有効活用　―具体例を通して学ぶ―

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<p>The utilization of a physiologically-based pharmacokinetic (PBPK) model has become prevalent, especially in drug development by pharmaceutical companies. The regulatory agencies in the US and Europe have already issued guidelines while the Japanese agency is preparing one to support the process. To some extent, applications of PBPK modeling to assess the risk of drug-drug interaction have mainly been discussed. It has been limited to discussing other utilizations such as: 1) conducting a virtual bioequivalence study for a new formulation; 2) assessing PK changes in a Japanese population; and 3) predicting PK profiles of drugs or drug candidates in pediatric subjects. The purpose of this paper is to discuss the current status and future challenges of potential utilizations of PBPK modeling through actual practices and to share regulatory experiences on PBPK modeling in Japan. We summarize the discussions on prospects from the perspective of industry, academia, regulatory agencies, and hospitals.</p><p></p>

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