Thursday 16 October, 2025
Objectives: In nonlinear mixed effect model (NLMEM), good estimation of individual parameters are necessary for treatment optimization, for sequential analysis…
Read morePoster: Methodology - Study Design
A bronchoalveolar lavage study design framework for characterization of the rate and extent of pulmonary distribution
Thursday 16 October, 2025
Objectives: Bronchoalveolar lavage (BAL) is a semi-invasive method that enables sampling and quantification of drug concentrations from epithelial lining fluid (ELF)…
Read moreModel-based dose selection for the Phase 2b study of ianalumab in primary Sjögren’s Syndrome
Thursday 16 October, 2025
Objectives: Ianalumab is a novel human monoclonal antibody (mAb) that binds to the B-cell Activating Factor receptor (BAFFr). It has…
Read moreDesign evaluation using a bootstrapped Monte Carlo variance-covariance matrix.
Thursday 16 October, 2025
Objectives: When evaluating study designs, methods based on Monte Carlo simulations such as Stochastic Simulation and Estimation (SSE) are considered the…
Read moreSample size calculations in multiple sclerosis using pharmacometrics methodology: comparison of a composite score continuous modeling and Item Response Theory approach
Thursday 16 October, 2025
Objectives: Clinical trials in multiple sclerosis (MS) therapeutic area are particularly long due to the variable and slowly progressive nature of…
Read moreGuidance on dose-finding studies for biostatisticians and pharmacometricians: a Pharmacometrics perspective
Thursday 16 October, 2025
Objectives: Finding the best dose and regimen is a key aspect of clinical development programs and quantitative line functions, such…
Read moreOptimal design of a reduced sampling schedule for the characterization of prolactin dynamics in healthy male volunteers and its evaluation to the describe the pharmacodynamic effect of a prolactin antagonist in a single rising dose study
Thursday 16 October, 2025
Objectives: Due to its involvement in dopaminergic pathways prolactin can be used as an endogenous biomarker for brain target engagement…
Read moreDesign and Interim Evaluation of a Sparse Sampling Schedule for Estimation of Individual Colistin Pharmacokinetics
Thursday 16 October, 2025
Objectives: As part of the EU funded AIDA project a multicenter, open-label, randomized 360 patient clinical trial (180 patients in each…
Read moreInformative study designs: The value of within-subject dose-escalation in the ‘Espresso design’
Thursday 16 October, 2025
Objectives: Drug development aims for most informative experimental designs while minimizing exposure of animals and patients to invasive procedures and…
Read moreSample size estimates for a clinical trial evaluating allometric dosing of miltefosine in children with visceral leishmaniasis in East Africa
Thursday 16 October, 2025
Objectives: We have previously shown that children treated with miltefosine for the neglected tropical parasitic disease visceral leishmaniasis (VL) are underexposed…
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