November 2, 2026
Date: November 2, 2026, 8:30 – 17:30
Location: Santiago de Chile, Chile
Instructors: Mike Tagen, PhD and Lucas Pereira
Traditional non-compartmental bioequivalence (BE) analysis struggles with complex scenarios like long-acting formulations or high variability due to intensive sampling demands. This workshop introduces model-based BE using population non-linear mixed-effects (NLME) modeling and simulation to handle sparse data, increase statistical power, and optimize trial designs.
Hands-on exercises in Pumas guide participants through a complete workflow: model setup, clinical trial simulation, BE assessment, and power and Type I error analysis. Real-world case studies cover long-acting injectables, baseline-corrected levothyroxine, narrow therapeutic index drugs, EMA reference-scaled BE, and pediatric extrapolation.
The workshop closes with validation methodology, including virtual cohorts and flexible sampling schedules. Attendees leave with reusable, executable Pumas code to apply these advanced techniques directly to their own trials.
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