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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S20] Drug Information on the Pharmacokinetics Section in the Japan Package Insert Can be Evolve Furthermore Attractively?

Session Chair(s)

Seongryul  Kim, PhD

Seongryul Kim, PhD

  • Director, Clinical Pharmacology, Headquarters of Clinical Development
  • Otsuka Pharmacetical Co., Ltd., 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.


Masanobu  Sato, PhD

Issues and Proposal on the Pharmacokinetics Section in the Japan Package Insert

Masanobu Sato, PhD

  • Senior Scientist, Clinical Pharmacokinetics & Pharmacometrics
  • MSD K.K., Japan
Taishi  Horiuchi

Regulatory Guidelines on Provision of Pharmacokinetic Information in Package Inserts of New Drugs

Taishi Horiuchi

  • Reviewer, Office of New Drug 4
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yoshiyuki  Ohno, PhD

Issues and Expectations of Pharmacokinetics Information in the Japan Package Insert at Medical Field

Yoshiyuki Ohno, PhD

  • The University of Tokyo Hospital, Japan