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 |
| Author: | Mark Sale  [aut,
cre] (Funded by FDA/NIH grant 1U01FD007355),
James Craig [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 |
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