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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.

Speaker(s)

Chieko  Muto, PhD

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

Chieko Muto, PhD

  • Clinical Pharmacologist, Clinical Pharmacology G 1, CP
  • Pfizer Japan Inc., Japan
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

  • Department of Pharmaceutical Medicine
  • Oita University Faculty of Medicine, Japan