built for Model Based Drug Development computing

Monolix is the most advanced and simple solution for non-linear mixed effects modeling (NLME) for pharmacometrics. It is based on the SAEM algorithm and provides robust, global convergence even for complex PK/PD models. Monolix is used for preclinical and clinical population PK/PD modeling and for Systems Pharmacology.

Monolix is used by a large and active user community

Benefit from a large user community, Monolix is widely used by academia, the pharmaceutical industry and the US (FDA) and European (EMA) regulatory agencies.

Advanced Statistical Methodologies

Reliable convergence for all type of data is a centerpiece in population PKPD modeling, which is why Lixoft pioneered in collaboration with Inria the SAEM algorithm.

Automated generation of diagnostic tests

Monolix automatically generates a full set of diagnostic plots even for complex PK/PD models. For example, you can instantaneously create the Visual Predictive Check, split by any patient subgroup you would want to investigate.

Increased productivity and quality

Efficient C++ solver package, standardized model language with Mlxtran, PK/PD model library and integrated software all contribute to better productivity and quality.

Ease of use

Our solutions are designed for ease of use. Monolix can be used via a graphical interface or command lines for powerful scripting. This means less programming for you and more focus on exploring models and pharmacology to deliver in time to your customers.

Key features

Support of all relevant data types and statistical features

Monolix covers a wide range of data types and statistical features for population PK/PD modeling. For all cases the right statistical methodology has been developed and published for reference. Monolix covers:

  • Continuous, categorical, count and repeated time to
    event data.
  • Mixture models and mixtures of models.
  • Inter-occasion variability with any number of levels.
  • Proper handling of BLQ data.
  • Normal, lognormal, logit, probit and user defined distributions for the individual parameters.

Comprehensive PK and PD library

Monolix provides a fully documented, open source library with 126 PK and 47 PD models.


Mlxtran is used for custom-built models; a simple, yet powerful model language that is suitable for simple as well as complex Systems Pharmacology models.

Comprehensive documentation and examples

Great care has been taken to provide the user with a comprehensive documentation that includes

  • Methodology manuals
  • Software manuals
  • Tutorials
  • Videos showing step-by-step instructions

A wide collection of examples that include models and data can be used as templates to start your own project.