关键词: 平均生物等效性, 群体生物等效性, 个体生物等效性用药可交替性, 处方可选择性

Abstract: The purpose of bioequivalence (BE)trial is to show that the test (T)and the reference (R)products can produce similarity bioavailability, and then show therapeutically equivalence.There are three types of bioequivalence, namely, average bioequivalence (ABE), population bioequivalence (PBE) and individual bioequivalence (IBE).The ABE approach focuses only on the comparison of population averages of a BE measure of interest and not on the variances of the measure for the T and R products.In contrast, the approaches to establish PBE and IBE include the comparisons of both averages and variances of the measure.The PBE approach assesses total variability of the measure in the population.While the IBE approach assesses within-subject variability for the T and R products, as well as the subject-by-formulation interaction, that is, the variation in the average T and R difference among individuals.In present paper ,the principle of the statistical approaches to establish BE ,the way to predetermine criterions and BE limits were introduced, and an example were illustrated.

Key words: average bioequivalence, population bioequivalence, individual bioequivalence, switchability, prescribability