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

摘要:
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。

Abstract:
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.