Drug Evaluation Committee Survey of Model-Informed Drug Development through Research on Products Approved in Japan
October 2023
The Drug Evaluation Committee’s Data Science Subcommittee Task Force 4 for fiscal year 2022 focused primarily on products approved between January 2020 and March 2022. Based on the approval information[Review Reports and Summary of Application Documents] to investigate the current state of Model-Informed Drug Development from various perspectives, including development phases, drug characteristics, and disease areas. We hope that this study will not only help clarify the current situation but also contribute to the understanding and dissemination of future related guidelines (such as ICH M15).
, Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee, Data Science Subcommittee
FY2022 Task Force 4 / FY2023 Continuing Task Force 4