R Observatory: Metrics for SimTOST version 1.0.2

Balamuta, James Joseph

doi:10.5281/zenodo.21843040

SimTOST

1.0.2

Sample Size Estimation for Bio-Equivalence Trials Through Simulation

0packages depend

2.5Kdownloads / year

45.7%test coverage

13/13checks pass

Overview

About

Maintained by Thomas DebrayFirst published 2025-02-182 releasesCRAN page ↗

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.

Install

R (CRAN)Ubuntu (r2u)Fedora (COPR)openSUSE (OBS)

install.packages("SimTOST", repos = "https://cloud.r-project.org/")

Installs the current CRAN release. Prebuilt binaries on Windows and macOS.

Release

# enable cranapt (r2u) if it is not already set up, then install
grep -rqs r2u.stat.illinois.edu /etc/apt/sources.list /etc/apt/sources.list.d/ \
  || curl -fsSL https://raw.githubusercontent.com/eddelbuettel/r2u/master/inst/scripts/add_cranapt_noble.sh | sudo bash
sudo apt install -y r-cran-simtost

Fast Ubuntu binaries via r2u (no compilation). The cranapt setup runs once and is skipped when it is already enabled.

bspm (used by r2u) also needs make: sudo apt install make

# enable the iucar/cran COPR if it is not already present, then install
ls /etc/yum.repos.d/*iucar*cran*.repo >/dev/null 2>&1 \
  || sudo dnf copr enable -y iucar/cran
sudo dnf install -y R-CRAN-SimTOST

RPMs from the iucar/cran COPR, rebuilt from CRAN.

For install.packages() integration in R, also: sudo dnf install R-CoprManager

# add the autoCRAN OBS repo (Tumbleweed) if it is missing, then install
zypper -q lr | grep -qi autoCRAN \
  || sudo zypper addrepo https://download.opensuse.org/repositories/devel:/languages:/R:/autoCRAN/openSUSE_Tumbleweed/devel:languages:R:autoCRAN.repo
sudo zypper install -y R-SimTOST

RPMs auto-built from CRAN on openSUSE OBS (Tumbleweed).

Health

CRAN checks

13OK

Slowest check: 12.5 min · r-devel-windows-x86_64

Code health

Yes

Tests · ratio 0.39

45.7%

Coverage · measured lines

100%

Documentation · exports

5

Dependencies · direct

Check history

OK2026-08-05
13 OK · 0 NOTE · 0 WARNING · 0 ERROR · 0 FAILURE
NOTE2026-08-01
12 OK · 1 NOTE · 0 WARNING · 0 ERROR · 0 FAILURE
OK2026-05-02
13 OK · 0 NOTE · 0 WARNING · 0 ERROR · 0 FAILURE
NOTE2026-04-22
12 OK · 2 NOTE · 0 WARNING · 0 ERROR · 0 FAILURE
ERROR2026-04-18
11 OK · 2 NOTE · 0 WARNING · 1 ERROR · 0 FAILURE

Show 1 earlier snapshots

NOTE2026-03-10
12 OK · 2 NOTE · 0 WARNING · 0 ERROR · 0 FAILURE

Documentation

READMEYes · 286 wordsVignettesYes · dynamicpkgdown siteNoNEWSYes · 100% structuredCode of conductNoContributing guideNo

Examples that run: 100%
Documented parameters: 99%
Return-value docs: 100%
References docs: 13%

Downloads

2.5K

CRAN downloads in the past year

Rank #20,741 · ~7/day · ~208/mo

Releases R versions

Daily download trend is not available in this view yet.

13430 days

53190 days

2.5K1 year

Compare downloads with other packages →

Also on375 r2u14 autocran

Repository

GitHub ↗ smartdata-analysis-and-statistics/simtost

3Stars

2Forks

1Open issues

0Open PRs

1Releases

157Commits

6Contributors

r-packagemcmctrial-simulationmulti-armmultiple-comparisonssample-size-calculationsample-size-estimation

License Apache-2.0 · 157 commits · Last activity 2025-06-16 · 0% stars, 30d

Stars over time

2025-02-19 · 22026-07-13 · 3

Repository practices

Upstream repositoryBeta

5 development-tooling and community-health practices detected across 4 families in the upstream repository

Checks run against github.com/smartdata-analysis-and-statistics/simtost on 2026-08-16.

Continuous integration (1)

GitHub Actions

CRAN release process (2)

cran-comments.mdCRAN-SUBMISSION

Docs source (1)

README.Rmd

Lint, format, editor (1)

RStudio project

How this is detected·Detection ruleset v1 (2026-07-18)

Dependencies

Declared dependencies

13 external dependencies (excludes base and recommended)

Depends (0)

none

Imports (5)

MASSRcpp data.table matrixcalcparallel

LinkingTo (2)

Rcpp RcppArmadillo

Suggests (8)

PowerTOST ggplot2 kableExtra knitr rmarkdown testthat tibble tinytest

Enhances (0)

none

Dependency license breakdown →

Reverse dependencies

0direct

0indirect

Nothing depends on this yet.

Code & Tests

People & History

People (7)

Maintainer (1)

Thomas Debray

Author, Maintainer

Authors (2)

Thomas Debray

Author, Maintainer

Johanna Munoz

Author

Contributors (4)

Contributor

Contributor

Contributor

Contributor

Copyright holders (1)

Biogen Inc

Copyright holder, Funder

Funders (1)

Biogen Inc

Copyright holder, Funder

Package Timeline

2 releases. Pick two to compare their code metrics. R releases are shown for context.

R
R 4.6.0 released · 2026-04-24
R
R 4.5.0 released · 2025-04-11
1.0.2Latest
2025-02-19 · current release · diff ↗
1.0.1
2025-02-18
R
R 4.4.0 released · 2024-04-24

Package metadata

First published: 2025-02-18
Total releases: 2 / 1 yrs
License: Apache License (>= 2)
Download size: 243 KB
Installed size: not tracked yet
With dependencies: not tracked yet

Cite

Cite this package

Run in R for the authors' preferred citation:

citation("SimTOST")

Format

Debray, T., Biogen Inc, Amaliah, D., McDonald, S., Mitroiu, M., Munoz, J., & Wei, W. (2025). SimTOST: Sample Size Estimation for Bio-Equivalence Trials Through Simulation (Version 1.0.2) [Computer software]. https://doi.org/10.32614/CRAN.package.SimTOST

This is what citation() produces when a package has no citation file of its own. If it prints something else, use that.

Cite the R Observatory

For a number measured here: a download total, a coverage figure, an archival date.

Format

APA

Balamuta, J. J. (2026). R Observatory: Metrics for SimTOST version 1.0.2 [Data set]. HJJB, LLC. Data release v2026-08-18. https://doi.org/10.5281/zenodo.21843040

From data release v2026-08-18, which the citation names so these numbers can be found later. More on citing and the projects behind them.

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