Thursday 16 October, 2025
Introduction: Conventionally, single arm dose-expansion trials were widely used to select the therapeutic dose for oncology. Many gaps in the conventional…
Read morePoster: Methodology - Model Evaluation
Utility of Physiologically-based Pharmacokinetic Model to Predict Inter-Antibody Variability in Monoclonal Antibody Pharmacokinetics
Thursday 16 October, 2025
Objectives: In this investigation, we test the hypothesis that within a PBPK framework, experimentally determined in vitro physiochemical assay metrics could…
Read moreA quantitative comparison of tumor sub-model variants in a minimal PBPK model for early clinical dose projections of antibody therapeutics in oncology
Thursday 16 October, 2025
Objectives: In drug development, accurate prediction of clinical pharmacokinetics (PK) and pharmacologically active doses is imperative to decision-making at all…
Read moreExternal evaluation of selected infliximab population pharmacokinetic models on patients with fistulizing Crohn’s disease
Thursday 16 October, 2025
Introduction: The development of fistulas in patients with Crohn’s disease is a recognised complication of this chronic disorder, posing challenges for…
Read moreImpact of censoring on non-linear effect modeling of aggregate-level survival data
Thursday 16 October, 2025
Introduction: Model-based meta-analysis (MBMA) applies statistical models to aggregate-level trial data to compare the treatment effects across studies using data…
Read moreExternal validation of population pharmacokinetic models on 7 published models of moxifloxacin-treated tuberculosis patients
Thursday 16 October, 2025
Object: Moxifloxacin has a potential role as a first-line agent in fluoroquinolone-based tuberculosis treatment and plays a central role in…
Read moreComparison of monoclonal antibody disposition predictions between different PBPK platforms
Thursday 16 October, 2025
Objectives: Most monoclonal antibodies (mAbs) target soluble- or membrane bound antigens located outside the vasculature [1]. While these concentrations at the…
Read moreCharacterizing Bootstrap Model Selection Variability Through an Automated Model Building Approach
Thursday 16 October, 2025
Introduction and Objectives:The development of a population pharmacokinetic (PK) model is a challenging and time-consuming procedure. There are several automatic…
Read moreEvaluation of the robustness of methods for model-based bioequivalence analysis for biosimilars: Clenoliximab as a case study
Thursday 16 October, 2025
Objectives: Regulatory approval of biosimilars includes comparison of the pharmacokinetic (PK) profiles of the biosimilar and the innovator reference product…
Read moreApplication of Structural Identifiability Analysis and Parametrisation of a Linear Mixed Effects Mirabegron Model
Thursday 16 October, 2025
Objectives: The application of structural identifiability analysis of a mathematical model is an essential step in its development to ensure…
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