Drug Evaluation Committee Survey of Model-Informed Drug Development through Research on Products Approved in Japan
Data Science Subcommittee
October 2023
Task Force 4 of the Drug Evaluation Committee's Data Science Subcommittee 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 summary of application materials] disclosed 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
Data Science Subcommittee of the Committee on Drug Evaluation
Task Force 4 in FY2022 / Continuing Task Force 4 in FY2023
DS Subcommittee FY2022 TF4 Deliverables
Deliverables of the Drug Evaluation Committee Return to list of all deliverables