MonolixSuite provides pharmacometricians with a unified environment for understanding variability, predicting outcomes, and informing better therapeutic decisions—transforming complex clinical data to actionable insights.

With MonolixSuite, you can:

  • Translate complex clinical data into robust population models 
  • Reveal exposure–response relationships that guide dose selection 
  • Understand variability across patient populations to improve safety and efficacy 
  • Simulate clinical trial scenarios before studies begin 
  • Generate transparent, reproducible analyses suitable for regulatory engagement 
A person with long blonde hair and glasses is smiling while using a laptop to explore Simulations Plus software solutions, such as ADMET Predictor and GastroPlus, showcasing performance metrics, medical research insights, and statistics in the background.

Focus on science, not software

For decades, pharmacometrics modeling and simulation have required extensive knowledge and complex coding environments.

MonolixSuite™ was designed differently. Its intuitive interface and integrated workflow allow pharmacometricians to focus on science rather than the software.
It streamlines your operations from data visualization and non-compartmental analysis to population modeling and simulations in a single environment.
This means you move from data to decision with greater clarity and speed—generating transparent, reproducible analyses that inform dose selection, trial design, and regulatory engagement.

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MonolixSuite pharmacometrics software dashboard

“The MonolixSuite is a cornerstone of our toolkit. Three key criteria make it indispensable for us: Reliability of integrated tools in complex modeling on tight schedules; Industry-level quality and adherence to rigorous industry standards; Swift and comprehensive customer support for technical and scientific queries.”

Matthias Machacek, Managing Director, LYO-X

“The MonolixSuite is an absolute game changer for pharmacometrics work. The ability to seamlessly move from population PK modeling in Monolix, to simulation in Simulx, and then exposure calculation in PKanalix expedites my workflow. Automatic plotting in all modules with the ability to format further cuts down on extra coding and QC time. Transferring code and profiles from module to module decreases QC time. Overall, the MonolixSuite makes my work more efficient and allows me to get results to clients faster.”

Jessica K. Roberts, Senior Director Pharmacometrics, Allucent

Execute end-to-end pharmacometric workflows
with precision

MonolixSuite integrates three interoperable applications—PKanalix, Monolix, and Simulx—that work seamlessly together. With it, you can:

  • Perform exploratory PK analysis and non-compartmental analysis (NCA) to get rapid insight from preclinical and clinical data 
  • Build population PK/PD models using nonlinear mixed-effects (NLME) methods 
  • Quantify variability and identify clinically meaningful covariate effects 
  • Evaluate exposure–response relationships to inform dose selection 
  • Simulate clinical trial scenarios and optimize dosing strategies  
  • Automate your analysis workflows and generate standardized reports 

MonolixSuite adapts to the scale and complexity of your modeling needs. Additional capabilities can be deployed when you need them.

  • A green hexagonal logo for Simulations Plus featuring a white arrow and circle, symbolizing movement. What’s included in PKanalix
    • Interactive visual tools for data exploration and customizable result displays 
    • Fully customizable NCA workflows and parameters 
    • Integrated bioequivalence analysis aligned with regulatory guidance 
    • Automated report generation and standardized outputs 
    • Reproducible and validated analyses with an integrated validation suite 
    • Compartmental analysis with seamless transition to population modeling and simulation 
  • The MonolixSuite logo, a teal hexagon, symbolizes cutting-edge pharmacometrics innovation. What’s included in Monolix
    • Population PK, PK/PD, and disease‑progression modeling 
    • NLME estimation powered by the SAEM algorithm 
    • Extensive editable model libraries supporting flexible and fast model definition 
    • Automated covariate analysis and variability characterization 
    • Diagnostic plots and goodness-of-fit assessment tools 
    • Model validation and uncertainty evaluation 
    • Transparent, reproducible workflows suitable for regulatory submission 
  • The orange hexagonal logo with a white arrow embodies Simulations Plus' dynamic software solutions. What’s included in Simulx
    • Clinical trial scenario simulation and virtual population generation 
    • Forward simulation to support model-informed decision-making 
    • Easy and flexible simulation setup and integrated post-processing tools 
    • Interactive exploration of effects of dosing regimens and model parameters 
A smiling man in a lab coat stands confidently, representing Simulations Plus QSP and PBPK expertise.

Resources
Training
Training

Instructor-led and on-demand courses to build your pharmacometric modeling expertise

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Documentation
Documentation

User guides, tutorials, and technical references to help you succeed

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Academic Request Form
Academic Request Form

Request access to the University+ academic program

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Webinars and Events
Webinars and Events

Join live webinars and events featuring experts and real-world use cases

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