test_studies

Internal function to estimate the bioequivalence test for nsim simulated studies given a sample size n

internal

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.

Thomas Debray

SimTOST

Sample Size Estimation for Bio-Equivalence Trials Through
Simulation

Johanna Munoz

Dewi Amaliah

Wei Wei

Marian Mitroiu

Scott McDonald

Biogen Inc 

test_studies function

<dl><dt>nsim</dt>
<dd>number of simulated studies</dd>
<dt>n</dt>
<dd>sample size</dd>
<dt>comp</dt>
<dd>index comparator</dd>
<dt>param</dt>
<dd>list of parameters (mean,sd,tar)</dd>
<dt>param.d</dt>
<dd>design parameters</dd>
<dt>arm_seed</dt>
<dd>seed for each endpoint to get consistent in simulations across all comparators</dd>
<dt>ncores</dt>
<dd>number of cores used for the calculation</dd></dl>

Arguments

test_studies — test_studies

<dl>

<dt>nsim</dt>
<dd>number of simulated studies</dd>


<dt>n</dt>
<dd>sample size</dd>


<dt>comp</dt>
<dd>index comparator</dd>


<dt>param</dt>
<dd>list of parameters (mean,sd,tar)</dd>


<dt>param.d</dt>
<dd>design parameters</dd>


<dt>arm_seed</dt>
<dd>seed for each endpoint to get consistent in simulations across all comparators</dd>


<dt>ncores</dt>
<dd>number of cores used for the calculation</dd>

</dl>

test_studies: test_studies

Description

Usage

Value

Arguments