New software for carrying out data analysis of bioavailability and bioequivalence testing
- VernacularTitle:生物利用度和生物等效性分析软件简介
- Author:
Zhiyang CHEN
;
Haitang XIE
;
Ruiyuan SUN
;
Gang HU
- Publication Type:Journal Article
- Keywords:
software;
analysis of variance;
crossover;
bioavailability;
average bioequivalence;
population bioequivalence种
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2007;12(4):448-454
- CountryChina
- Language:Chinese
-
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 (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.
