Transl Clin Pharmacol.  2020 Dec;28(4):175-180. 10.12793/tcp.2020.28.e20.

Bioequivalence data analysis

• Park G
• Kim H
• Bae KS

• KMID: 2512009
• DOI: http://doi.org/10.12793/tcp.2020.28.e20

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.

Keyword

SAS^®; GLM; MIXED; sasLM; nlme