mlxDesignEval: A Novel R Package for Design Evaluation Based on MonolixSuite

Authors: Cellière G, Pierre M, Twarogowska M, Chauvin J
Conference: PAGE
Keywords: clinical trials, MonolixSuite, PKPD modeling, R package
Software: Monolix®, Simulx®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Introduction

  • When clinical trial data is used to fit population PK/PD models, one may design the trial to optimize the parameter estimation of the model [1].
  • This consists of determining sampling times, number of individuals, dose groups, that enable estimating the population parameters with high confidence (i.e., with low relative standard errors – RSE).
  • An efficient approach uses the Fisher Information Matrix (FIM) and a first-order approximation around the typical population parameter values [2].
  • The FIM approach is implemented in the R packages popED [3] and PFIM [4], but their usage is limited because their model definition language differs from the language used by NLME model estimation software.

By Géraldine Cellière, Matthias Pierre, Monika Twarogowska, Jonathan Chauvin

PAGE 2025, Thessaloniki, Greece, June 3-6, 2025