关键词: 软件, 方差分析, 交叉, 生物利用度, 平均生物等效性, 群体生物等效性

Abstract: Generic drug products (test products: drug A, B...) are bioequivalent to an innovator product (reference product) when their bioavailabilities in the same molar dose are similar.Bioavailability is usually expressed by following pharmacokinetic parameters:the area under plasma concentration-time curve (AUC), the maximum plasma concentration (C_max) and the time of maximum plasma concentration (t_max).This paper used a two period crossover bioequivalence study to develop convenient, friendly user interface software, BA&BE Analysis to statistically process data in clinical pharmacology studies and other areas.The method involves user input of data for analysis into a grid format, setting variables and parameters, followed by one-way analysis of variance (ANOVA), bioavailability and bioequivalence analysis of the data.The software developed in the present study should help scientists to carry out data analysis of bioavailability and bioequivalence testing quickly and easily.

Key words: software, analysis of variance, crossover, bioavailability, average bioequivalence, population bioequivalence