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DESCRIPTION

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Package: SimTOST
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Title: Sample Size Estimation for Bio-Equivalence Trials Through Simulation
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Version: 1.0.0
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Version: 1.0.1
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Authors@R: c(
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person(given = "Thomas",
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family = "Debray",
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role = c("ctb")),
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person("Biogen Inc", role = c("cph", "fnd"))
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)
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Description: Conducts sample size estimation for bio-equivalence trials using the Two One-Sided Tests procedure. A simulation-based approach enables flexible hypothesis testing, supports multiple treatments, and accommodates correlated endpoints.
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Description:
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Sample size estimation for bio-equivalence trials is supported through a simulation-based approach
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that extends the Two One-Sided Tests (TOST) procedure. The methodology provides flexibility in
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hypothesis testing, accommodates multiple treatment comparisons, and accounts for correlated endpoints.
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Users can model complex trial scenarios, including parallel and crossover designs, intra-subject variability,
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and different equivalence margins. Monte Carlo simulations enable accurate estimation of power and type I error
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rates, ensuring well-calibrated study designs. The statistical framework builds on established methods for
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equivalence testing and multiple hypothesis testing in bio-equivalence studies, as described in Schuirmann (1987)
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<doi:10.1007/BF01068419>, Mielke et al. (2018) <doi:10.1080/19466315.2017.1371071>, Shieh (2022)
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<doi:10.1371/journal.pone.0269128>, and Sozu et al. (2015) <doi:10.1007/978-3-319-22005-5>.
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Comprehensive documentation and vignettes guide users through implementation and interpretation of results.
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License: Apache License (== 2.0)
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Encoding: UTF-8
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Roxygen: list(markdown = TRUE)

NEWS.md

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# SimTOST 1.0.1
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- Fixed CRAN review issues: expanded description, added references, documented function outputs.
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# SimTOST 1.0.0
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* Initial CRAN submission.
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# SimTOST 0.6.0
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# SimTOST 0.1.0
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* Initial CRAN submission.
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R/SampleSize.R

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#' }
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#'
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#' @references
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#' Mielke, J., Jones, B., Jilma, B., & König, F. (2018). Sample size for multiple hypothesis testing in biosimilar development. \emph{Statistics in Biopharmaceutical Research, 10}(1), 39-49.
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#' Schuirmann, D. J. (1987). A comparison of the Two One-Sided Tests procedure and the
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#' Power approach for assessing the equivalence of average bioavailability.
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#' \emph{Journal of Pharmacokinetics and Biopharmaceutics, 15}(6), 657-680.
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#' <doi:10.1007/BF01068419>
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#'
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#' Berger, R. L., & Hsu, J. C. (1996). Bioequivalence trials, intersection-union tests, and equivalence confidence sets. \emph{Statistical Science}, 283-302.
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#' Mielke, J., Jones, B., Jilma, B., & König, F. (2018). Sample size for multiple hypothesis
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#' testing in biosimilar development. \emph{Statistics in Biopharmaceutical Research, 10}(1), 39-49.
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#' <doi:10.1080/19466315.2017.1371071>
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#'
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#' Berger, R. L., & Hsu, J. C. (1996). Bioequivalence trials, intersection-union tests, and
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#' equivalence confidence sets. \emph{Statistical Science}, 283-302.
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#'
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#' Sozu, T., Sugimoto, T., Hamasaki, T., & Evans, S. R. (2015). "Sample Size Determination in
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#' Clinical Trials with Multiple Endpoints." \emph{SpringerBriefs in Statistics}.
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#' <doi:10.1007/978-3-319-22005-5>
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#'
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#' @author Johanna Muñoz \email{johanna.munoz@fromdatatowisdom.com}
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#'

R/helper.r

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#' Display the summary results of the sample size estimation
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#' Print Summary of Sample Size Estimation
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#'
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#' @description
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#' Prints the summary results of the sample size estimation for bioequivalence trials,
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#' including achieved power, total sample size, and power confidence intervals.
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#' The function also details the study design, primary endpoint comparisons,
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#' and applied multiplicity corrections.
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#'
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#' @details
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#' This function displays the summary results of the sample size estimation.
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#' This function displays key metrics from a sample size estimation analysis.
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#' It provides an overview of the study design, treatment comparisons,
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#' tested endpoints, significance level adjustments, and estimated sample size.
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#' For studies with multiple primary endpoints, it describes the multiplicity correction applied.
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#'
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#' @param x An object of class `"simss"`, typically generated by a sample size estimation function.
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#' @param ... Optional arguments to be passed from or to other methods.
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#'
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#' @return No return value, called for side effects. The function prints the summary results
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#' of the sample size estimation to the console in a structured format.
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#'
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#' @param x An object of class "simss"
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#' @param ... Optional arguments to be passed from or to other methods.
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#' @author
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#' Thomas Debray \email{tdebray@fromdatatowisdom.com}
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#'
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#' @method print simss
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#' @export
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print.simss <- function(x, ...) {

README.Rmd

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<!-- badges: start -->
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[![R-CMD-check](https://github.com/smartdata-analysis-and-statistics/SimTOST/actions/workflows/R-CMD-check.yml/badge.svg)](https://github.com/smartdata-analysis-and-statistics/SimTOST/actions/workflows/R-CMD-check.yml)
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[![CRAN status](https://www.r-pkg.org/badges/version/SimTOST)](https://CRAN.R-project.org/package=SimTOST)
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[![Codecov test coverage](https://codecov.io/gh/smartdata-analysis-and-statistics/SimTOST/branch/main/graph/badge.svg)](https://app.codecov.io/gh/smartdata-analysis-and-statistics/SimTOST?branch=main)
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[![metacran downloads](https://cranlogs.r-pkg.org/badges/last-month/SimTOST)](https://cran.r-project.org/package=SimTOST)
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<!-- badges: end -->
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`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.

README.md

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[![R-CMD-check](https://github.com/smartdata-analysis-and-statistics/SimTOST/actions/workflows/R-CMD-check.yml/badge.svg)](https://github.com/smartdata-analysis-and-statistics/SimTOST/actions/workflows/R-CMD-check.yml)
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[![CRAN
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status](https://www.r-pkg.org/badges/version/SimTOST)](https://CRAN.R-project.org/package=SimTOST)
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[![Codecov test
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coverage](https://codecov.io/gh/smartdata-analysis-and-statistics/SimTOST/branch/main/graph/badge.svg)](https://app.codecov.io/gh/smartdata-analysis-and-statistics/SimTOST?branch=main)
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[![metacran
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downloads](https://cranlogs.r-pkg.org/badges/last-month/SimTOST)](https://cran.r-project.org/package=SimTOST)
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<!-- badges: end -->
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`SimTOST` is an R package specifically designed for bioequivalence

man/print.simss.Rd

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man/sampleSize.Rd

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