Drug Evaluation Committee
The Potential of Bioequivalence Evaluation Using Physiological Drug Absorption Models
~Current Status and Future Prospects of Virtual BE
Data Science Expert Committee
In
July 2026
, the Data Science Subcommittee of the Drug Evaluation Committee’s FY2025 Continuing Task Force 6 conducted a survey on Virtual Bioequivalence (VBE), covering its basic concepts, trends among domestic and international regulatory authorities, actual use cases, and currently available tools.This report clarifies the potential and challenges of VBE as of 2026 and provides guidance to support its scientific and practical implementation by offering insights into future prospects and recommended approaches. We hope this report will be helpful in the utilization of VBE.