Objectives: The objective of dose finding studies is to identify the relationship between dose and efficacy to guide selection of…
Read morePoster: Study Design
Platform for adaptive optimal design of nonlinear mixed effect models.
Introduction: Recent years have seen an increasing interest in adaptive trial design methodologies. With the growing use of nonlinear mixed…
Read moreModeling and simulation to optimise the study design investigating the hemodialysis of dabigatran in patients with end stage renal disease (ESRD)
Objectives: To define a study design that allows investigation of the influence of hemodialysis on the steady state exposure of…
Read moreComparison of results of the different software for design evaluation in population pharmacokinetics and pharmacodynamics
Objectives: To compare the standard errors (SE) and criterion provided by the different software for population designs on two examples:…
Read moreNew version of PFIM for optimal design in nonlinear mixed effects models using R S4
Introduction: Nonlinear mixed effect models are increasingly used for the analysis of longitudinal studies in drug development. Using the Fisher…
Read moreSimulation study for a potential sildenafil survival trial in adults with pulmonary arterial hypertension (PAH) using a time-varying exposure-hazard model developed from data in children
Objectives: Sildenafil (REVATIO®), 20mg TID, received approval for the treatment of adult PAH in US and EU. A pediatric study…
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