Drug Evaluation Committee Survey of Model-Informed Drug Development through Research on Products Approved in Japan
Data Science Subcommittee
October 2023
The Drug Evaluation Committee's Data Science Subcommittee Task Force 4 for FY2022 will conduct a survey on the actual state of Model-Informed Drug Development in drug development, mainly for items approved between January 2020 and March 2022, based on the approval information [review reports and summaries of application materials] made public by the PMDA. The survey was conducted from various perspectives, such as development phase, drug characteristics, and disease areas, based on the approval information [review reports and summary of application materials] disclosed by PMDA. We hope that this survey will be helpful not only in understanding the actual situation, but also in understanding and disseminating the related notifications (ICH M15, etc.) in the future.
Japan Pharmaceutical Manufacturers Association
Drug Evaluation Committee Data Science Subcommittee
Task Force 4 in FY2022 / Continuing Task Force 4 in FY2023