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SimTOST  

Sample Size Estimation for Bio-Equivalence Trials Through Simulation
View on CRAN: Click here


Download and install SimTOST package within the R console
Install from CRAN:
install.packages("SimTOST")

Install from Github:
library("remotes")
install_github("cran/SimTOST")

Install by package version:
library("remotes")
install_version("SimTOST", "1.0.2")



Attach the package and use:
library("SimTOST")
Maintained by
Thomas Debray
[Scholar Profile | Author Map]
All associated links for this package
First Published: 2025-02-18
Latest Update: 2025-02-18
Description:
Sample size estimation for bio-equivalence trials is supported through a simulation-based approach that extends the Two One-Sided Tests (TOST) procedure. The methodology provides flexibility in hypothesis testing, accommodates multiple treatment comparisons, and accounts for correlated endpoints. Users can model complex trial scenarios, including parallel and crossover designs, intra-subject variability, and different equivalence margins. Monte Carlo simulations enable accurate estimation of power and type I error rates, ensuring well-calibrated study designs. The statistical framework builds on established methods for equivalence testing and multiple hypothesis testing in bio-equivalence studies, as described in Schuirmann (1987) <doi:10.1007/BF01068419>, Mielke et al. (2018) <doi:10.1080/19466315.2017.1371071>, Shieh (2022) <doi:10.1371/journal.pone.0269128>, and Sozu et al. (2015) <doi:10.1007/978-3-319-22005-5>. Comprehensive documentation and vignettes guide users through implementation and interpretation of results.
How to cite:
Thomas Debray (2025). SimTOST: Sample Size Estimation for Bio-Equivalence Trials Through Simulation. R package version 1.0.2, https://cran.r-project.org/web/packages/SimTOST. Accessed 30 Jul. 2026.
Previous versions and publish date:
(2026-07-09 08:26), 1.0.1 (2025-02-18 11:10)
Other packages that cited SimTOST R package
View SimTOST citation profile
Other R packages that SimTOST depends, imports, suggests or enhances
Complete documentation for SimTOST
Functions, R codes and Examples using the SimTOST R package
Full SimTOST package functions and examples
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