Poster: Methodology - Study Design

Assessment of Sample Size Allocation for A Multi-regional Phase 2 Trial: Comparison of Statistical and Dose-Exposure-Response (D-E-R) Approaches

Thursday 16 October, 2025

Introduction: Global simultaneous drug development has become a common practice in multinational pharmaceutical companies to reduce the time lag to…

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Unlocking efficiency in dose selection based on pharmacokinetic-pharmacodynamic modeling of tumor size data: Insights from Clinical Trial Simulations

Thursday 16 October, 2025

Objectives:  Dose optimization is a critical objective of early clinical development of oncology drugs. The value of longitudinal tumor size…

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A comparative analysis of Bayesian dose-finding designs incorporating pharmacokinetics information

Thursday 16 October, 2025

Introduction: In most Phase I and Phase I/II studies in patients, dose-finding and pharmacokinetics/pharmacodynamics (PK/PD) are still analyzed separately [1]….

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Modelling framework to simulate phenotypic results of antiviral PROTACs

Thursday 16 October, 2025

Objectives: Proteolysis-targeting chimeras (PROTAC) are novel chemical concepts taking advantage of the proteasome to degrade target proteins. Compared to PROTACs…

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Individualized tacrolimus dosing in pediatric kidney transplantation: development of PBPK-based predictive models, simulations and applications (ModSimTer-Tacro Study)

Thursday 16 October, 2025

Objectives: Development of individual dosage (ID) methods is a long-standing goal pursued by clinicians. Therapeutic individualization requires processing a significant…

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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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