Design and Result Evaluation of Pilot Bioequivalence

The result of pilot bioequivalence can be used to optimize the protocol of pivotal study, evaluate the feasibility of the test preparations to carry out pivotal trial, and predict the sample size of pivotal study, which plays an increasingly important role in the clinical development of generic drugs. The pilot bioequivalence study lack of well-established design and analysis methods may make a wrong estimate of true test-reference ratio and intrasubject variability, thus affecting the subsequent development strategy. In this review, based on relevant literatures and guidelines, the design and statistical method of pilot bioequivalence were systematically described. The review focused on how to scientifically evaluate the pharmaceutical development strategy of generic drugs based on the results of pilot study, so as to provide reference for applicants.