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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V3-S4] Future Perspectives of Effective Drug Interaction Evaluation - Comparison among Japan, US and EU Regulatory Documents -

Session Chair(s)

Naomi  Nagai, PhD

Naomi Nagai, PhD

Professor, Faculty of Pharmacy

Musashino University, Japan

Japanese drug interaction guideline is now in the finalization phase (as of June, 2018). Although an international harmonization is being pursued with the cutoff criteria in decision trees and index drugs recommended for the use in drug interaction studies, there are still some differences in the Japanese, US and EU regulatory documents. In recent years, physiologically-based pharmacokinetic (PBPK) modeling & simulation have been effectively used, and its usefulness is mentioned in the documents. Application of appropriate models to predict drug interactions enables to improve the efficiency of drug interaction studies at the drug development stage. We discuss how to examine future drug interaction studies with comparing the regulatory documents for drug interaction studies announced from Japan, US and EU.


Akihiro  Hisaka, PhD

Outline of Japanese Drug Interaction Guideline and its Scientific Significance

Akihiro Hisaka, PhD

Graduate School of Pharmaceutical Sciences, Chiba University, Japan

Professor, Laboratory of Clinical Pharmacology and Pharmacometrics

Kazuya  Maeda, PhD

International Harmonization of the Regulatory Documents for Drug Interaction

Kazuya Maeda, PhD

Graduate School of Pharmaceutical Sciences, The University of Tokyo, Japan

Lecturer, Laboratory of Molecular Pharmacokinetics

Yuki  Matsumoto, MS

Investigation of Drug Interaction Using PBPK Model

Yuki Matsumoto, MS

MSD K.K., Japan

Clinical Pharmacokinetics & Pharmacometrics Gr,Clinical Pharmacology Development