Thursday 16 October, 2025
Objectives: To introduce and unveil the properties of a two-stage design (TSD) for bioequivalence (BE) studies. Methods: A TSD with…
Read morePoster: Study Design
Pharmacokinetic-Pharmacodynamic Modelling & Simulation of Org 52186, a V3 antagonist, in Support of a Challenge Agent Trial Design with dDAVP
Thursday 16 October, 2025
Objectives: Org 52186, a V3 antagonist, was in development as an agent against depression before being discontinued. The objective of this…
Read moreHow to support a definitive bioequivalence study design using modeling and simulation
Thursday 16 October, 2025
Objectives: The objective was to perform population pharmacokinetic (PK) modeling and clinical trial simulations (CTS) to inform the study design…
Read moreUsing Placebo FEV1 Response to Improve the efficiency of clinical trials in Asthma
Thursday 16 October, 2025
Objectives: To evaluate the efficiency of new clinical trial design in asthma where subjects are randomised to study treatments based…
Read moreModeling and Simulation of Pharmacokinetics and H3 Receptor Occupancy for Dose Setting in a Phase IIa Study
Thursday 16 October, 2025
Objectives: AZD5213 is a histamine 3 (H3) autoreceptor antagonist currently under development for symptomatic treatment of Alzheimer's disease. Sleep disturbances…
Read moreEfficiency criteria generated by optimal design tools should be evaluated in the light of study objectives
Thursday 16 October, 2025
Objectives: The definition of an optimal sampling schedule is of particular importance in applying sparse sampling strategies in clinical studies…
Read moreUsing modeling and simulation to evaluate placebo run-in for pain studies
Thursday 16 October, 2025
Objectives: In clinical trials investigating the treatment effect on neuropatic pain, the treatment effect is often compared at end of…
Read moreStochastic Simulations Assist to Improve a Poorly Designed Clinical Study for the CSF Pharmacokinetics of Doripenem
Thursday 16 October, 2025
Objectives: To assess the impact of the addition of new subjects, with improved sampling design to the results of a…
Read moreMultiple Model Optimal Experimental Design for Pharmacokinetic Applications
Thursday 16 October, 2025
Objective: To develop an experiment design approach for multiple model problems where the population model associated with the Bayesian prior…
Read moreImproved dose selection for PET occupancy studies
Thursday 16 October, 2025
Objectives: Receptor occupancy can be assessed by Positron Emission Tomography (PET). Since PET measurements are very expensive it is important…
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