derive_endpoint_names

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 

derive_endpoint_names function

<dl><dt>ynames_list</dt>
<dd>Optional list of vectors with endpoint names for each arm.</dd>
<dt>mu_list</dt>
<dd>Named list of means per treatment arm, where names can be used as endpoint names.</dd>
<dt>verbose</dt>
<dd>Logical, if <code>TRUE</code>, displays messages about the derivation process.</dd></dl>

Arguments

Thomas Debray <a href="/link/tdebray%40fromdatatowisdom.com?package=SimTOST&version=1.0.2" data-mini-rdoc="SimTOST::tdebray@fromdatatowisdom.com">tdebray@fromdatatowisdom.com</a>
This function derives endpoint names (<code>ynames_list</code>) from <code>mu_list</code> if <code>ynames_list</code>
is missing. If <code>ynames_list</code> is already provided, it confirms the names to the user when
<code>verbose</code> is set to <code>TRUE</code>.

Author

Derive Endpoint Names — derive_endpoint_names

<dl>

<dt>ynames_list</dt>
<dd>Optional list of vectors with endpoint names for each arm.</dd>


<dt>mu_list</dt>
<dd>Named list of means per treatment arm, where names can be used as endpoint names.</dd>


<dt>verbose</dt>
<dd>Logical, if <code>TRUE</code>, displays messages about the derivation process.</dd>

</dl>

Thomas Debray <a href='mailto:tdebray@fromdatatowisdom.com'>tdebray@fromdatatowisdom.com</a>
This function derives endpoint names (<code>ynames_list</code>) from <code>mu_list</code> if <code>ynames_list</code>
is missing. If <code>ynames_list</code> is already provided, it confirms the names to the user when
<code>verbose</code> is set to <code>TRUE</code>.

derive_endpoint_names: Derive Endpoint Names

Description

Usage

Value

Arguments

Author