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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
Principal Scientist, PKPD & PMx,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
Group lead, Clinical Pharmacology & Bioanalytics, Pfizer Japan Inc., Japan
Application of PBPK Modeling Leading to More Efficient Drug Development – Overview and Case Examples -
Shinichi Kijima
, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Current State of New Drug Review Utilizing PBPK Modeling and Developing PBPK Modeling Guideline
Naoto Uemura, MD, PhD
Professor and Head of Clinical Pharmacology and General Clinical Research Center, Oita University Faculty of Medicine, Japan
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