Bioequivalence data analysis

ABSTRACT

SAS® is commonly used for bioequivalence (BE) data analysis. R is a free and open software for general purpose data analysis, and is less frequently used than SAS® for BE data analysis. This tutorial explains how R can be used for BE data analysis to generate comparable results with SAS® . The main SAS® procedures for BE data analysis are PROC GLM and PROC MIXED, and the corresponding R main packages are “sasLM” and “nlme” respectively. For fixed effects only or balanced data, the SAS® PROC GLM and R “sasLM” provide good estimates; however, for a mixed-effects model with unbalanced data, the SAS® PROC MIXED and R “nlme” are better for providing estimates without bias. The SAS® and R scripts are provided for convenience.