mbbe

Model Based Bio-Equivalence

James Craig, Mark Sale, Michael Tomashevskiy

Last update: 3 February 2024

Copyright license: GNU Lesser General Public License, version 3.0

Software version identifier: 0.1.0

Description

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>.

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