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 |