mbbe: Model Based Bio-Equivalence

Uses several Nonlinear Mixed effect (NONMEM) models (as NONMEM control files) to perform bootstrap model averaging and Monte Carlo Simulation for Model Based Bio-Equivalence (MBBE). Power is returned as the fraction of the simulations with successful bioequivalence (BE) test, for maximum concentration (Cmax), Area under the curve to the last observed value (AUClast) and Area under the curve extrapolate to infinity (AUCinf). See Hooker, A. (2020) Improved bioequivalence assessment through model-informed and model-based strategies <https://www.fda.gov/media/138035/download>.

Version: 0.1.0
Imports: dplyr, stringr, xml2, PKNCA, magrittr, nlme, emmeans, future, furrr (≥ 0.3.1), processx, tictoc, ggplot2, ps, jsonlite
Suggests: knitr, rmarkdown, testthat
Published: 2024-02-03
DOI: NA
Author: Mark Sale ORCID iD [aut, cre] (Funded by FDA/NIH grant 1U01FD007355), James Craig ORCID iD [aut], Michael Tomashevskiy [aut]
Maintainer: Mark Sale <mark.sale at certara.com>
BugReports: https://github.com/certara/mbbe/issues
License: LGPL-3
URL: https://github.com/certara/mbbe
NeedsCompilation: no
Materials: README
CRAN checks: mbbe results

Documentation:

Reference manual: mbbe.pdf
Vignettes: Introduction
Step-by-Step

Downloads:

Package source: mbbe_0.1.0.tar.gz
Windows binaries: r-devel: mbbe_0.1.0.zip, r-release: mbbe_0.1.0.zip, r-oldrel: mbbe_0.1.0.zip
macOS binaries: r-release (arm64): mbbe_0.1.0.tgz, r-oldrel (arm64): mbbe_0.1.0.tgz, r-release (x86_64): mbbe_0.1.0.tgz, r-oldrel (x86_64): mbbe_0.1.0.tgz

Linking:

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