Back to Agenda
[V3-S4] Future Perspectives of Effective Drug Interaction Evaluation - Comparison among Japan, US and EU Regulatory Documents -
Session Chair(s)
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.
Speaker(s)
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
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
Investigation of Drug Interaction Using PBPK Model
Yuki Matsumoto, MS
MSD K.K., Japan
Clinical Pharmacokinetics & Pharmacometrics Gr,Clinical Pharmacology Development
Have an account?