Drug Evaluation Committee Issues and Current Status in Bioequivalence Assessment of Drugs with Large Intra-individual Variation
December 2023
In the ICH M13 (Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms), which is currently under review, discussions are scheduled to take place regarding methods for evaluating bioequivalence (BE) of highly variable drugs (HVDs).Since it is well known that criteria for HVDs and the statistical methods for their BE assessment vary among regulatory authorities, Task Force 6 of the Data Science Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) determined that it was necessary to assess the current status of BE evaluation for HVDs and identify challenges for international coordination.Therefore, this Task Force reviewed the content of guidance documents issued by various regulatory authorities and conducted statistical analyses based on them to identify challenges and considerations for bioequivalence assessments of HVDs.Furthermore, the Task Force conducted a case study of BE trials for HVDs approved in Japan and carried out a questionnaire survey of domestic pharmaceutical companies regarding the conduct of HVD BE trials, summarizing the results. We hope this report will contribute to international coordination in the BE evaluation of HVDs.
Japan Pharmaceutical Manufacturers Association (
) Drug Evaluation Committee, Data Science Subcommittee (
) FY2021 Task Force 6 / FY2022–2023 Continuing Task Force 6