Drug Evaluation Committee Issues and Current Status in Bioequivalence Assessment of Drugs with Large Intra-individual Variation
Data Science Subcommittee
December 2023
In ICH M13 (Guidelines for Immediate-Release Solid Oral Dosage Forms Bioequivalence), which is currently under review, a discussion is planned on how to evaluate the bioequivalence (BE) of Highly Variable Drugs (HVDs). Since it is known that the criteria for HVDs and statistical evaluation methods for their BEs differ among regulatory authorities, Task Force 6 of the Data Science Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) considered it necessary to understand the current status of BE evaluation for HVDs and to identify issues for international collaboration. Therefore, this task force organized the contents of the guidance issued by each regulatory authority and conducted a statistical study based on the guidance in order to summarize the issues and points to be considered in bioequivalence evaluations for HVDs. In addition, we conducted a case study of BE studies of HVDs approved in Japan and a questionnaire survey of domestic pharmaceutical companies regarding the implementation of BE studies of HVDs, and summarized the results. We hope that this report will contribute to international cooperation in BE evaluation of HVDs.
Japan Pharmaceutical Manufacturers Association
Drug Evaluation Committee Data Science Subcommittee
2021 Task Force 6 / 2022-2023 Ongoing Task Force 6