基于SAS、R和WinNonLin软件实现药动学参数计算及生物等效性分析

Pharmacokinetic Parameters Calculation and Bioequivalence Analysis Based on SAS,R and WinNonLin Software

目的使用SAS、R和WinNonLin软件计算药动学参数并进行生物等效性分析。方法通过SAS软件的“Proc reg”和“Proc mixed”过程步、R语言软件的“NonCompart”包和“nlme”包以及WinNonLin软件实现计算药动学参数,并建立混合效应模型,用双单侧t检验和90%置信区间判断生物等效性。结果使用SAS、R和WinNonLin软件计算的药动学参数和生物等效性结果一致。结论通过SAS、R和WinNonLin软件可以实现药动学参数计算及生物等效性分析,结果准确可靠。

OBJECTIVE To calculate pharmacokinetic parameters and bioequivalence analysis through SAS,R,and WinNonL in software.METHODS The SAS"proc reg"and"proc mixed"procedures,the R"NonCompart"and"nlme"packages,and WinNonLin software were used to calculate pharmacokinetic parameters and construct a linear mixed-effects model.Used two one-sided t-tests and the 90%confidence interval to determine bioequivalence.RESULTS The pharmacokinetic parameters and bioequivalence results calculated using SAS,R and WinNonLin software were consistent.CONCLUSION The pharmacokinetic parameters calculation and bioequivalence analysis can be achieved through SAS,R,and WinNonLin software with accurate and reliable result.