Objectives: Model evaluation has become a key component of the modelling process. In this respect, Visual Predictive Checks (VPC) are…
Read moreOral Presentation: Methodology
Rapid sample size calculations for a defined likelihood ratio test-based power in mixed effects models
Objectives: Efficient power calculation methods have previously been suggested for Wald test based inference in mixed effects models (1) but…
Read moreD-optimal Adaptive Bridging Studies in Pharmacokinetics
Background: Bridging studies are a method for extrapolating information gathered from clinical study in an original region (prior population), e.g….
Read moreStandardized Visual Predictive Check – How and When to used it in Model Evaluation
Objectives: PK/PD modeling is increasingly used in drug development, and model evaluation has become an important component in the modeling…
Read moreMaximum likelihood estimation in nonlinear mixed effect models: Adaptive Gaussian Quadrature by sparse grid sampling
Objectives: Compartment models for PK population modeling are often nonlinear mixed effect models (NLME) with normal distributed random effects and…
Read moreTrial predictions vs. trial simulations in early clinical development: a framework to evaluate the predictive probability of success based on NONMEM outputs
Objective: In a Model-Based Drug Development strategy, the very first objective is to design studies such that the most reliable…
Read moreStochastic pharmacokinetic models: selection of sampling times
Introduction and Objectives: We discuss pharmacokinetic (PK) studies which are described by compartmental models. Traditionally, ordinary differential equations (ODE) are…
Read moreIntegrated model for clinical response and dropout in depression trials: a state-space approach
Objectives: GSK372475 is an equipotent reuptake inhibitor of serotonin, norepinephrine and dopamine neuronal reuptake and has been investigated as a…
Read moreImprovements and New Estimation Methods in NONMEM 7 for PK/PD Population Analysis
Objective: To demonstrate NONMEM 7's improvements and additional estimation methods for population analysis Methods: The NONMEM 7 software has been…
Read moreEstimating the kinetic parameters of vascular tumor growth models to optimize anti-angiogenesis drugs delivery
Objectives: Optimizing the delivery of anti-angiogenesis drugs requires the development of relevant drug-disease models of vascular tumor growth. We aim…
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