Package: SimTOST 1.0.2

Thomas Debray

SimTOST: Sample Size Estimation for Bio-Equivalence Trials Through Simulation

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.

Authors:Thomas Debray [aut, cre], Johanna Munoz [aut], Dewi Amaliah [ctb], Wei Wei [ctb], Marian Mitroiu [ctb], Scott McDonald [ctb], Biogen Inc [cph, fnd]

SimTOST_1.0.2.tar.gz
SimTOST_1.0.2.zip(r-4.7)SimTOST_1.0.2.zip(r-4.6)SimTOST_1.0.2.zip(r-4.5)
SimTOST_1.0.2.tgz(r-4.6-x86_64)SimTOST_1.0.2.tgz(r-4.6-arm64)SimTOST_1.0.2.tgz(r-4.5-x86_64)SimTOST_1.0.2.tgz(r-4.5-arm64)
SimTOST_1.0.2.tar.gz(r-4.7-arm64)SimTOST_1.0.2.tar.gz(r-4.7-x86_64)SimTOST_1.0.2.tar.gz(r-4.6-arm64)SimTOST_1.0.2.tar.gz(r-4.6-x86_64)
SimTOST_1.0.2.tgz(r-4.6-emscripten)
manual.pdf |manual.html✨
DESCRIPTION |NEWS
card.svg |card.png
SimTOST/json (API)

# Install 'SimTOST' in R:
install.packages('SimTOST', repos = c('https://smartdata-analysis-and-statistics.r-universe.dev', 'https://cloud.r-project.org'))

Bug tracker:https://github.com/smartdata-analysis-and-statistics/simtost/issues

Pkgdown/docs site:https://smartdata-analysis-and-statistics.github.io

Uses libs:
  • openblas– Optimized BLAS
  • c++– GNU Standard C++ Library v3

On CRAN:

Conda:

mcmcmulti-armmultiple-comparisonssample-size-calculationsample-size-estimationtrial-simulationopenblascpp

5.32 score 2 stars 7 scripts 247 downloads 33 exports 5 dependencies

Last updated from:0f2b394faf. Checks:13 OK. Indexed: yes.

TargetResultTimeFilesSyslog
linux-devel-arm64OK155
linux-devel-x86_64OK159
source / vignettesOK301
linux-release-arm64OK184
linux-release-x86_64OK158
macos-release-arm64OK187
macos-release-x86_64OK354
macos-oldrel-arm64OK164
macos-oldrel-x86_64OK246
windows-develOK158
windows-releaseOK130
windows-oldrelOK153
wasm-releaseOK144

Exports:check_equivalenceconfint.simssderive_allocation_ratederive_arm_namesderive_endpoint_namesderive_varcov_listget_parinfo_msgmcsapplyplot.simsspower_calpower_dompower_Mielkeprint.simssptvptvdfrun_simulations_2x2_domrun_simulations_2x2_romrun_simulations_par_domrun_simulations_par_romsampleSizesampleSize_Mielkesign_MielkesimParallelEndpointssummary.simsstest_2x2_domtest_2x2_romtest_par_domtest_par_romtest_studiesuniroot.integer.modvalidate_positive_definitevalidate_sample_size_limits

Dependencies:data.tableMASSmatrixcalcRcppRcppArmadillo

Introduction
Hypotheses | Difference of Means (DOM) | Ratio of Means (ROM) | Regulatory Requirements | Testing of multiple endpoints | Testing multiple co-primary endpoints | Testing multiple primary endpoints | Bonferroni correction | Sidak correction | K adjustment | Hierarchical testing of multiple endpoints | Testing of multiple treatments | References
Rendered fromintropkg.Rmdusingknitr::rmarkdown

Last update: 2025-02-13
Started: 2025-01-22

Bioequivalence Tests for Parallel Trial Designs: 2 Arms, 3 Endpoints
Introduction | Testing multiple co-primary endpoints | Independent Testing of Co-Primary Endpoints | Simultaneous Testing of Independent Co-Primary Endpoints | Simultaneous Testing of Correlated Co-Primary Endpoints | Testing multiple primary endpoints | Simultaneous Testing of Primary Endpoints | Hierarchical Testing of Endpoints | References
Rendered fromsampleSize_parallel_2A3E.Rmdusingknitr::rmarkdown

Last update: 2025-02-13
Started: 2025-01-08

Bioequivalence Tests for 2x2 Cross-Over Trial Designs with Log-Normal Data
Bioequivalence Tests for AUC and Cmax | References
Rendered fromsampleSize_crossover.Rmdusingknitr::rmarkdown

Last update: 2025-02-13
Started: 2024-11-17

Bioequivalence Tests for Parallel Trial Designs: 2 Arms, 1 Endpoint
Introduction | Difference of Means Test | Scenario | Trial Design | Objective | Implementation | References
Rendered fromsampleSize_parallel_2A1E.Rmdusingknitr::rmarkdown

Last update: 2025-02-13
Started: 2025-01-12

Bioequivalence Tests for Parallel Trial Designs: 3 Arms, 1 Endpoint
Introduction | Sample Size Calculation for AUCinf: Equivalence to EU Remicade | Hypotheses | Preparing the function arguments | Computing Sample Size | Sample Size Calculation for AUCinf: Equivalence to US Remicade and EU Remicade | Implementation Details | Results and Interpretation | References
Rendered fromsampleSize_parallel_3A1E.Rmdusingknitr::rmarkdown

Last update: 2025-02-13
Started: 2025-01-06

Bioequivalence Tests for Parallel Trial Designs: 3 Arms, 3 Endpoints
Introduction | Input Data | Simultaneous Testing of Independent Co-Primary Endpoints | Different Hypotheses across endpoints | Simultaneous Testing of Independent Primary Endpoints | Equivalence for At Least 2 of the 3 Endpoints with Bonferroni Adjustment | Unequal Allocation Rates Across Arms | Accounting for Participant Dropout | References
Rendered fromsampleSize_parallel_3A3E.Rmdusingknitr::rmarkdown

Last update: 2025-02-13
Started: 2025-01-11

Bioequivalence Tests for Parallel Trial Designs with Log-Normal Data
Multiple Independent Co-Primary Endpoints | Approach 1: Using sampleSize_Mielke | Approach 2: Using sampleSize | Multiple Correlated Co-Primary Endpoints | References
Rendered fromsampleSize_parallel.Rmdusingknitr::rmarkdown

Last update: 2025-01-28
Started: 2024-11-18