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Getting Started with Non-Linear Mixed Effects: Exploring Population Analysis with Real-World Examples

Presented 26 March 2024 by Drs. Johan Gabrielsson and Bernd Wendt

Updated this week

Webinar Overview (Part 1 of 2024 Webinar Series)

This webinar is the first in a four-part series recorded in 2024, in which the authors extend the concepts from the widely used textbook PK/PD Data Analysis: Concepts and Applications (5th Edition) toward material planned for a future 6th Edition. While the book focuses primarily on individual (naïve pooled) analyses, this webinar series introduces population-based approaches using non-linear mixed-effects (NLME) modeling.

The authors present the PK52 case study from the book, illustrating the use of population modeling to analyze pharmacokinetic data. The example examines a short half-life, renally eliminated antioxidant studied in normal and renal-clamped rats, highlighting the concept of effective half-life. The analysis supports the design of a first-in-human constant-infusion PK study.

In this webinar, the authors demonstrate how to:

  • Simulate population-level datasets from published mean PK data in both rat groups

  • Introduce realistic assumptions for within-subject and between-subject variability

  • Fit the same structural PK model using population (NLME) methods rather than individual analyses

  • Use population modeling results to better support translational PK understanding and study design

This session provides a practical introduction to population analysis and sets the foundation for subsequent webinars in the series.

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