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Case Studies

  • Introduction to time-to-event modeling

    In the MonolixSuite, the mlxtran language facilitates the description and modeling of time-to-event data. This introduction provides an overview of time-to-event modeling within Monolix, covering various modeling approaches and detailing typical parametric models that are commonly used for this type of analysis.

  • A TTE model for the NCCTG lung cancer study

    This case study shows how to build and validate a parametric survival model using the NCCTG lung cancer dataset, identify key covariates, and simulate survival in new patient cohorts. The step-by-step workflow uses Monolix, Simulx, and R to support prognosis and explore the impact of patient characteristics on survival outcomes.

  • A simple TTE model for the Veterans’ Administration Lung Cancer study

    This case study shows how to build and validate a parametric survival model using a lung cancer dataset, identify key covariates, and simulate survival in new patient cohorts. The step-by-step workflow uses Monolix, Simulx, and R to support prognosis and explore the impact of patient characteristics on survival outcomes.

  • Tobramycin dose individualization

    In this example modeling and simulation workflow, we model tobramycin pharmacokinetics and simulate dosing regimens in patients with various degrees of renal function impairment.

  • Modeling of Tisagenlecleucel CAR-T cells

    In this case study, we show how Monolix is used to develop a model for the kinetics of tisagenlecleucel and the impact of therapies for treating cytokine release syndrome (tocilizumab and corticosteroids) on expansion.

  • Simulating and Evaluating Clinical Trial Designs for Pediatric Populations

    This case study is for modelers designing pediatric PK trials. It shows how to use simulation and re-estimation to evaluate how precisely model parameters can be estimated with a given design. The step-by-step workflow helps ensure your trial collects data reliable enough for modeling and decision-making.

  • QSP Modeling: FAAH Inhibitor Case Study

    This case study demonstrates application of Quantitative Systems Pharmacology (QSP) modeling in drug development, using the example of a Fatty Acid Amide Hydrolase (FAAH) inhibitor. It is a practical, step-by-step guide to build, calibrate, and use a QSP model to address key questions. It shows how to integrate various data sources—from in vitro and preclinical studies to human clinical data—to build a robust mechanistic model. This case study also explains the impact of the sensitivity analysis and uncertainty assessment, showing how these techniques can inform critical go/no-go decisions and guide future research.