Introduction: Global simultaneous drug development has become a common practice in multinational pharmaceutical companies to reduce the time lag to…
Read morePoster: Methodology - Study Design
Unlocking efficiency in dose selection based on pharmacokinetic-pharmacodynamic modeling of tumor size data: Insights from Clinical Trial Simulations
Objectives: Dose optimization is a critical objective of early clinical development of oncology drugs. The value of longitudinal tumor size…
Read moreA comparative analysis of Bayesian dose-finding designs incorporating pharmacokinetics information
Introduction: In most Phase I and Phase I/II studies in patients, dose-finding and pharmacokinetics/pharmacodynamics (PK/PD) are still analyzed separately [1]….
Read moreModelling framework to simulate phenotypic results of antiviral PROTACs
Objectives: Proteolysis-targeting chimeras (PROTAC) are novel chemical concepts taking advantage of the proteasome to degrade target proteins. Compared to PROTACs…
Read moreIndividualized tacrolimus dosing in pediatric kidney transplantation: development of PBPK-based predictive models, simulations and applications (ModSimTer-Tacro Study)
Objectives: Development of individual dosage (ID) methods is a long-standing goal pursued by clinicians. Therapeutic individualization requires processing a significant…
Read moreInfluence of interoccasion variability on parameter estimates of a population pharmacokinetic model under various sparse study designs
Objectives:Sampling schemes to inform pharmacokinetic (PK) modelling in phase II clinical studies are sparse. Typically, sampling is performed in a…
Read moreEstablishment of Virtual Bioequivalence via DoE-PBPM Model: A Donepezil Case Study
Objectives: Donepezil (DZP) is a medication used to treat Alzheimer’s disease. It works by inhibiting the breakdown of acetylcholine in…
Read moreDesign 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
Objectives: Eosinophilic esophagitis (EoE) is a chronic, progressive, type 2 inflammatory disease of the esophagus that substantially impairs quality of…
Read moreBone Remodeling QSP to Guide Clinical Trial Design of WNT pathway inhibitors
Objectives: Targeting WNT signalling pathways has emerged as an attractive strategy to treat multiple diseases, including in oncology. WNT also plays…
Read moreEmpirical Power Evaluations of an Item Response Model in Parkinson’s Disease Patients
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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