Objectives: How to proceed when heterogeneous population data are intended to be analyzed by means of a parametric population method like…
Read morePoster: Methodology- Design
Optimal Design for the improvement of sampling schedules of microdialysis studies.
Objectives: The methods of Optimal Design have been explored for various applications, but not for the design of sampling schedules…
Read moreThe Effect of Study Design on Pharmacokinetics in Patients with Impaired Renal Function
Objectives: To ensure the effect of renal function on drug exposure is precisely quantified, FDA guidance recommends that studies recruit…
Read moreThe Use of Clinical Trial Simulation to investigate Bias in Crossover Studies with a Short Washout Period and no Placebo Arm: Application to Neuropathic Pain
Objectives: Clinical trials in neuropathic pain are often run in parallel designs. The placebo response following administration of drugs such…
Read moreDose escalation studies: a comparison between NONMEM and a novel Bayesian tool
Objectives: Evaluate modeling approaches and decision making criteria in dose escalating Phase I studies. In these studies, subjects receive increasing…
Read moreMean Squared Error as Criterion for Sampling Schedule Optimization for Individual Dose Targeting in IV Busulfan
Objectives: Pharmacokinetics-based dose targeting of daily IV busulfan is routinely performed to achieve a narrow plasma exposure of busulfan to…
Read morePopulation methods for dose escalation studies: an MCMC approach
Objectives: In dose escalation studies decisions must be taken on the next doses to be administered based on safety and PK outcomes….
Read morePrediction of power of test of discrete covariates in population analyses and influence of design: application to gender effect in joint pharmacokinetic models of nucleoside analogs and their active metabolites
Objectives: To predict power of test of gender effect and to study the influence of design in population pharmacokinetic (PK)…
Read moreNew features for population design evaluation and optimisation using PFIM3.2: illustration on warfarin pharmacokinetics – pharmacodynamics
Objectives: We developed the free R function PFIM [1] for population design evaluation and optimisation. Here, we illustrate the use…
Read morePopulation design in nonlinear mixed effects multiple responses models: extension of PFIM and evaluation by simulation with NONMEM and MONOLIX
Objectives: Multiple responses are increasingly used in population analyses. In this context, efficient tools for population designs evaluation and optimisation…
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