MonolixSuite

MonolixSuite™, developed by Simulations Plus, is a fast, easy-to-use, and powerful suite of applications purpose-built for Model Informed Drug Development (MIDD) computing. It is designed for pharmacometricians and drug development scientists working on preclinical and clinical population PK/PD modeling, non-compartmental analysis (NCA), and systems pharmacology simulations. The suite is trusted across industry and academia for its reliability, adherence to rigorous industry standards, and comprehensive customer support.

MonolixSuite provides a fully interoperable set of applications that deliver a complete modeling and simulation workflow — from data visualization and non-compartmental analysis through to population modeling and simulations — combining intuitive usability with advanced calculation capabilities.

Suite Modules

• Monolix® — An easy, fast, and powerful tool for parameter estimation in non-linear mixed effect (NLME) models, model diagnosis and assessment, and advanced graphical representation, supporting population PK/PD analysis.
• PKanalix® — Dedicated to PK/PD non-compartmental analysis, enabling robust NCA parameter calculation and data exploration.
• Simulx® — A simulation application for PK/PD modeling, enabling clinical trial simulation and model-based drug development workflows.

What's New in MonolixSuite v2024

• Integrated Bootstrap — Bootstrap functionality is now built in, with results displayed directly in the Monolix results tab.
• Plot Presets — Users can transfer plot customization between plots and save presets to apply consistent formatting across other projects.
• Faster Performance — Improved speed for reloading projects, generating plots, and running analyses.
• Expanded Dataset Compatibility — Input datasets in SAS and Excel formats are now supported.
• Sparse Data Option — A new option allows calculation of NCA parameters from mean profiles, supporting sparse sampling designs.
• Enhanced NCA Outputs — Addition of a table of concentrations, custom NCA parameters, and ratio calculations.

Key Capabilities and Workflow

• Full pharmacometrics workflow from data visualization and NCA through to population modeling and clinical simulation.
• Non-linear mixed effects (NLME) modeling for population PK/PD analysis in both preclinical and clinical settings.
• Advanced graphical representation and model diagnosis tools for thorough model assessment.
• Interoperability across all suite modules, enabling seamless transitions between analysis steps.
• Support for model-informed precision dosing and clinical trial optimization workflows.

MonolixSuite is available for download with academic license options and is supported by extensive documentation, video tutorial series, and an active scientific community. The suite is actively developed and regularly updated, with Simulations Plus providing swift technical and scientific customer support to meet the demands of complex modeling on tight schedules.