Poster: Study Design

Improved study design in phase IIb by the use of optimal design, focusing on the precision of dose finding

Thursday 16 October, 2025

Objectives: The objective of dose finding studies is to identify the relationship between dose and efficacy to guide selection of…

Read more

Platform for adaptive optimal design of nonlinear mixed effect models.

Thursday 16 October, 2025

Introduction: Recent years have seen an increasing interest in adaptive trial design methodologies. With the growing use of nonlinear mixed…

Read more

Modeling and simulation to optimise the study design investigating the hemodialysis of dabigatran in patients with end stage renal disease (ESRD)

Thursday 16 October, 2025

Objectives: To define a study design that allows investigation of the influence of hemodialysis on the steady state exposure of…

Read more

Comparison of results of the different software for design evaluation in population pharmacokinetics and pharmacodynamics

Thursday 16 October, 2025

Objectives: To compare the standard errors (SE) and criterion provided by the different software for population designs on two examples:…

Read more

New version of PFIM for optimal design in nonlinear mixed effects models using R S4

Thursday 16 October, 2025

Introduction: Nonlinear mixed effect models are increasingly used for the analysis of longitudinal studies in drug development. Using the Fisher…

Read more

Simulation 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

Thursday 16 October, 2025

Objectives: Sildenafil (REVATIO®), 20mg TID, received approval for the treatment of adult PAH in US and EU. A pediatric study…

Read more