Context: Group comparaison methods for Non-linear mixed effects models (NLMEM) enable to identify parameters whose estimations significantly vary across the…
Read moreOral: Stuart Beal Methodology Session
Simulated model based adaptive optimal design of adult to children bridging study using FDA stopping criteria.
Objectives: In traditional design, the size of the study population is regularly calculated a priori using power calculations which are dependent…
Read morePrediction of pharmacokinetic interactions for drugs with a long half-life – evidence for the need of model-based analysis
Objectives: DDI studies are commonly performed as single-dose crossover studies where AUC and Cmax w/wo perpetrator drug are compared [1,2]. The…
Read moreAveraged Model Based Decision Making for Dose Selection Studies
Objective: Approximately one third of the cost of a drug development program incurs in Phase III clinical studies, hence the correctness…
Read morePreconditioning of Nonlinear Mixed Effect models for Stabilization of the Covariance Matrix Computation
Objectives: As the importance of pharmacometric analysis increases, more and more complex models are introduced and computational stability starts to become a bottleneck. We…
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