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SimTOST is an R package designed to facilitate the sample size estimation for bioequivalence studies using a simulation-based approach.

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SimTOST

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The goal of SimTOST is to estimate the sample size sample size for a randomized, three-arm, parallel group phase I trial via simulation.

Installation

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")

Vignettes

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

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

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SimTOST is an R package designed to facilitate the sample size estimation for bioequivalence studies using a simulation-based approach.

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