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[S20] Drug Information on the Pharmacokinetics Section in the Japan Package Insert Can be Evolve Furthermore Attractively?
Session Chair(s)
Seongryul Kim, PhD
Director, Clinical Pharmacology, Headquarters of Clinical Development
Otuska Pharmaceutical, Japan
Information of pharmacokinetics in Japan package insert is based on traditional practice so far. Providing DDI information and utilization of modeling and simulation data on Japan package insert is described in the DDI guideline issued in 2018 and Population PK/PD analysis guideline issued in 2019 in Japan. In this session, we will share issues and proposals in such a change and consider collaboration with industry, government and academia for appropriate presentation of drug information based on the latest science, such as the utilization of forest plots on drug interactions and covariates, and the simulation data based on PopPK, PKPD and PBPK.
Speaker(s)
Issues and Proposal on the Pharmacokinetics Section in the Japan Package Insert
Masanobu Sato, PhD
MSD K.K., Japan
Senior Scientist, Clinical Pharmacokinetics & Pharmacometrics
Regulatory Guidelines on Provision of Pharmacokinetic Information in Package Inserts of New Drugs
Taishi Horiuchi
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of New Drug 4
Issues and Expectations of Pharmacokinetics Information in the Japan Package Insert at Medical Field
Yoshiyuki Ohno, PhD
The University of Tokyo Hospital, Japan