生物利用度和生物等效性分析软件简介(英文)

New software for carrying out data analysis of bioavailability and bioequivalence testing

考虑生物利用度的影响因素,仿制药物(或制剂)与参比对象采用相同的等效剂量,应能达到生物等效。生物利用度一般用以下几个药代动力学参数衡量:曲线下面积(AUC),峰浓度(Cmax),达峰时间(tmax)。本论文以双交叉生物等效性试验为例,介绍自主开发的生物等效性分析软件BA&BE,该软件使用便捷、界面友好,可用于临床药理和新药研发等相关领域。软件允许用户直接在网格界面进行数据录入,设置变量和参数。系统便可自行对原始数据进行方差分析(ANOVA)、生物利用度和生物等效性的计算并生成报表。该软件将有助于科研人员更迅速、准确地进行数据分析和提交结果。

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 （ Cmax ） and the time of maximum plasma concentration （tmax）. 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.