Abstract: Objective To explain the considerations of investigators in the design and implementation of bioequivalence(BE) studies based on risk management strategies, so as to provide references for preventing potential security risks in large-scale BE studies in China. Methods Based on the general process of risk management and a dabigatran BE study, the research design and implementation were considered from the aspects of risk identification, risk assessment, risk decision-making, risk monitoring. Results The risk of bleeding was identified as an important risk in the study, and the risk level was evaluated according to the location and amount of bleeding. No bleeding and related adverse events occurred in the study, and all subjects were safely excluded from the study. Conclusion The risk management of this study has achieved the expected goals, which confirms the scientificity and effectiveness of the design and implementation based on risk management.

Key words: risk management, bioequivalence, dabigatran, risk identification, risk assessment, risk decision, risk monitoring and control