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Tokyo Big Sight

Nov 10, 2019 9:30 AM - Nov 12, 2019 5:40 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S29] Leveraging Physiological Pharmacokinetic (PBPK) Analysis for Development After Issuing Official Guidance the Potential Impacts of PBPK Analysis on Japan Submission

Session Chair(s)

Atsunori  Kaibara, PhD

Atsunori Kaibara, PhD

Research Advisor, Medicines Development Unit Japan

Eli Lilly Japan K.K., Japan

This session outlines the potential impact of PBPK after issuing the new guideline for non-clinical pharmacology experts. Throughout the session, we will share the perspectives of experts from industry, government, and academia on the number of clinical pharmacology studies necessary in submission by appropriately utilizing PBPK and how to balance actual clinical practice and simulation in drug development. In the panel discussion, the PBPK experts will discuss how to effectively utilize PBPK as an efficient tool for clinical development as well as useful bed-side information for appropriate drug use. We will also discuss the necessity and danger of applying simulation data as an alternative of actual clinical data.


Chieko  Muto, PhD

Application of PBPK Modeling Leading to More Efficient Drug Development – Overview and Case Examples -

Chieko Muto, PhD

Pfizer Japan Inc., Japan

Clinical Pharmacologist, Clinical Pharmacology G 1, CP

Shinichi  Kijima

Current State of New Drug Review Utilizing PBPK Modeling and Developing PBPK Modeling Guideline

Shinichi Kijima

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Naoto  Uemura, MD, PhD

Naoto Uemura, MD, PhD

Oita University Faculty of Medicine, Japan

Vice Dean and Professor, Department of Clinical Pharmacology and Therapeutics

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