Introduction to Monolix

Monolix is a cutting-edge, user-friendly solution for non-linear mixed effects modeling (NLME) in pharmacometrics. Powered by the SAEM algorithm, it ensures robust and reliable convergence, even for complex PK/PD models with dense or sparse, continuous or non-continuous data. Widely adopted across academia, the pharmaceutical industry, and regulatory agencies, Monolix supports modeling needs from preclinical research to clinical development and systems pharmacology.

The Monolix streamlines the entire modeling process, from exploratory analysis to regulatory submission. Analyses performed with Monolix are accepted by agencies such as the EMA and FDA, which hold licenses for the software. As detailed in the documentation it ensures quality control, reproducibility and consistency of the analysis.

This documentation is for Monolix starting from 2018 version. For documentation of previous versions, please check Legacy Documentation.