Objectives:Sampling schemes to inform pharmacokinetic (PK) modelling in phase II clinical studies are sparse. Typically, sampling is performed in a…
Read morePoster: Methodology - Study Design
Establishment 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…
Read moreModel-informed trial design for the malaria transmission blocking antibody TB31F
Introduction: TB31F is a transmission-reducing monoclonal antibody targeting a highly conserved epitope of the malaria gametocyte [1]. A previous study…
Read morePharmacokinetic Modeling of Fentanyl Citrate and Norfentanyl in Calves Using a Nonlinear Mixed-Effects Approach
Objectives: Fentanyl citrate is a potent opioid agonist commonly used as an analgesic in animal studies, providing several hours of…
Read moreOptimizing the sample size of a bridging study using Simulx, an application of the MonolixSuite
Objectives: Clinical trial simulations can guide the design of phase 3 trials, e.g. by suggesting the minimum sample size required…
Read moreEvaluating two strategies for the design of pediatric pharmacokinetic studies
Objectives: Designing pediatric clinical trials are complicated by the large range of body sizes and developmental changes in the population…
Read moreA Bayesian Optimization Procedure for the Automated Determination of Optimal Limited Sampling Strategies
Introduction: Pharmacokinetic (PK) guided dosing is a common approach for personalising prophylactic treatment of haemophilia A patients receiving standard or…
Read more