• Live Workshops
An Introductory Workshop in Pharmacometrics Using MonolixSuite®
  • -
  • 8:00 AM EST to 5:30 PM EST
  • The Niagara Falls Convention Center (NFCC)
  • Register

This three-day interactive workshop, hosted by the University of Buffalo’s School of Pharmacy and Pharmaceutical Sciences, will guide you through the essentials of population pharmacokinetic/pharmacodynamic (PK/PD) modeling while building the practical skills needed to apply these methods in research and development. By the end, you will be able to build, refine, and simulate models with confidence using MonolixSuite®.

Workshop Synopsis

The program is tailored for a broad audience:

  • Students and beginners who are just starting with pharmacometrics and want a solid introduction.
  • Intermediate modelers seeking to strengthen their approach to model development and simulations.
  • Experienced users aiming to streamline workflows, run efficient simulations, and adopt best practices for reproducibility and regulatory submissions.

Through a balanced mix of lectures, hands-on practice, and discussions, the workshop builds both understanding and applied expertise. Realistic case studies guide participants through complete workflows — from data exploration and model development to simulations of dosing regimens and clinical trials. Exercises mirror the day-to-day work of a modeller, integrating customization, reproducibility, and automation, while providing guidelines to accelerate workflows and comply with FDA and EMA standards.

No prior experience with MonolixSuite® is required. A temporary MonolixSuite® license is provided to all participants to continue practicing after the workshop.

Learning Objectives

Following this workshop, participants will:

  • Gain a solid background in the population modeling approach with nonlinear mixed-effects (NLME) models, understanding when and why to use them, with foundational knowledge in PK and PD modeling.
  • Learn the importance of data exploration for successful model development, including data formatting, visualization, and diagnostic tools for identifying trends, variability, and potential covariates.
  • Develop skills in model building, from defining structural and statistical models to stepwise covariate analysis, model comparison, and refinement strategies.
  • Understand technical aspects of model selection and evaluation, using diagnostic plots, statistical criteria, and algorithm settings to assess model performance and reliability.
  • Acquire proficiency in simulations with Simulx, including comparisons of dosing regimens, evaluation of patient variability, and design of clinical trial scenarios.
  • Practice workflow optimization, applying presets, automation, and reproducibility tools to streamline modeling tasks and ensure consistency across projects.
  • Build confidence in mlxtran for writing and adapting models, enabling flexibility in model specification and control of advanced features.
  • Gain hands-on experience with lixoft Connectors in R to script workflows, automate tasks, and ensurere producibility of analyses.
  • Apply best practices in model development, diagnosis, reporting, and regulatory compliance, aligning analyses with FDA and EMA guidelines.

Instructors

The workshop is organized and taught by experienced pharmacometricians and MonolixSuite® specialists from Simulations Plus. We have been providing clinical pharmacology and pharmacometrics software and consulting services, including population PK/PD modeling and simulation, to the global pharmaceutical industry for over 25 years to generate and communicate the knowledge required for time-sensitive decision-making and regulatory review.