Different cases studies are presented here to show how to use Monolix and the MonolixSuite for Modeling and Simulation.
Tobramycin case study
This case study presents the modeling of the tobramycin pharmacokinetics, and the determination of a priori dosing regimens in patients with various degrees of renal function impairment. It takes advantage of the integrated use of Datxplore for data visualization, Mlxplore for model exploration, Monolix for parameter estimation and Simulx for simulations and best dosing regimen determination.
Longitudinal Model-Based Meta-Analysis (MBMA) with Monolix Suite
Longitudinal model-based meta-analysis (MBMA) models can be implemented using the MonolixSuite. These models use study-level aggregate data from the literature and can usually be formulated as non-linear mixed-effects models in which the inter-arm variability and residual error are weighted by the number of individuals per arm. We exemplify the model development and analysis workflow of MBMA models in Monolix using a real data set for rheumatoid arthritis, following publication from Demin & al (2012). In the case study, the efficacy of a drug in development (Canakinumab) is compared to the efficacy of two drugs already on the market (Adalimumab and Abatacept). Simulations using Simulx were used for decision support to see if the new drug has a chance to be a better drug.
The full test case can be seen here. We present how to implement and analyze a longitudinal MBMA model with Monolix and Simulx along with global guidelines for the implementation of your project.
Analysis of time-to-event data
Within the MonolixSuite, the mlxtran language allows to describe and model time-to-event data using a parametric approach. We first give an introduction on time-to-event data, the different ways to model this kind of data, and typical parametric models. A library of common TTE models is also provided. Next two modeling and simulation workflows are detailed, using two TTE data sets.