SimTOST is an R package specifically designed for
bioequivalence studies, providing simulation-based sample size
estimation for the Two One-Sided Tests (TOST) procedure. It offers
flexible options to handle complex study designs, including trials with
multiple correlated primary endpoints, multiple hypotheses, and
treatment arms. By incorporating correlations between endpoints,
SimTOST ensures accurate and robust planning of
bioequivalence trials, making it a powerful tool for studies with
intricate requirements.
SimTOST is available on CRAN and can be installed by
running the following code.
install.packages("SimTOST")You can also install the development version of SimTOST from GitHub with:
# install.packages("devtools")
devtools::install_github("smartdata-analysis-and-statistics/SimTOST")The main features of this package is sampleSize function
which can be used to calculate sample size for individual and multiple
endpoints. Various worked examples are available as vignettes,
with an introduction provided at Introduction.
| Vignette | Design | Number of Arms | Number of Endpoints |
|---|---|---|---|
| Bioequivalence Tests for Parallel Trial Designs with Log-Normal Data | Parallel | 2 | Multiple (e.g., 2 or 3) |
| Bioequivalence Tests for 2x2 Cross-Over Trial Designs with Log-Normal Data | Cross-over | 2 | 2 |
| Bioequivalence Tests for Parallel Trial Designs: 2 Arms, 1 Endpoint | Parallel | 2 | 1 |
| Bioequivalence Tests for Parallel Trial Designs: 3 Arms, 1 Endpoint | Parallel | 3 | 1 |
| Bioequivalence Tests for Parallel Trial Designs: 2 Arms, 3 Endpoints | Parallel | 2 | 3 |
| Bioequivalence Tests for Parallel Trial Designs: 3 Arms, 3 Endpoints | Parallel | 3 | 3 |