Poster: Methodology - Study Design

Influence of interoccasion variability on parameter estimates of a population pharmacokinetic model under various sparse study designs

Thursday 16 October, 2025

Objectives:Sampling schemes to inform pharmacokinetic (PK) modelling in phase II clinical studies are sparse. Typically, sampling is performed in a…

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Establishment of Virtual Bioequivalence via DoE-PBPM Model: A Donepezil Case Study

Thursday 16 October, 2025

Objectives: Donepezil (DZP) is a medication used to treat Alzheimer’s disease. It works by inhibiting the breakdown of acetylcholine in…

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Design of a Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Children Aged 1-11 Years, With Active Eosinophilic Esophagitis

Thursday 16 October, 2025

Objectives: Eosinophilic esophagitis (EoE) is a chronic, progressive, type 2 inflammatory disease of the esophagus that substantially impairs quality of…

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Bone Remodeling QSP to Guide Clinical Trial Design of WNT pathway inhibitors

Thursday 16 October, 2025

Objectives: Targeting WNT signalling pathways has emerged as an attractive strategy  to treat multiple diseases, including in oncology. WNT also plays…

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Empirical Power Evaluations of an Item Response Model in Parkinson’s Disease Patients

Thursday 16 October, 2025

Objectives:  The Unified Parkinson’s Disease Rating Scale (UPDRS), a multi-item symptom evaluation tool that included three sub scales, is the…

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Model-informed trial design for the malaria transmission blocking antibody TB31F

Thursday 16 October, 2025

Introduction: TB31F is a transmission-reducing monoclonal antibody targeting a highly conserved epitope of the malaria gametocyte [1]. A previous study…

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Pharmacokinetic Modeling of Fentanyl Citrate and Norfentanyl in Calves Using a Nonlinear Mixed-Effects Approach

Thursday 16 October, 2025

Objectives: Fentanyl citrate is a potent opioid agonist commonly used as an analgesic in animal studies, providing several hours of…

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Optimizing the sample size of a bridging study using Simulx, an application of the MonolixSuite

Thursday 16 October, 2025

Objectives: Clinical trial simulations can guide the design of phase 3 trials, e.g. by suggesting the minimum sample size required…

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Evaluating two strategies for the design of pediatric pharmacokinetic studies

Thursday 16 October, 2025

Objectives: Designing pediatric clinical trials are complicated by the large range of body sizes and developmental changes in the population…

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A Bayesian Optimization Procedure for the Automated Determination of Optimal Limited Sampling Strategies

Thursday 16 October, 2025

Introduction: Pharmacokinetic (PK) guided dosing is a common approach for personalising prophylactic treatment of haemophilia A patients receiving standard or…

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