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[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
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)
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
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
Oita University Faculty of Medicine, Japan
Vice Dean and Professor, Department of Clinical Pharmacology and Therapeutics