Thursday 16 October, 2025
INTRODUCTION A limitation in antitubercular drug development remains the empiricism based on which companion drugs and their dose rationale are…
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Copula modeling for realistic virtual patient covariate simulation
Thursday 16 October, 2025
Objectives: Simulation of virtual patients is a commonly applied procedure in pharmacometrics for optimizing dosing regimens and clinical trial simulation. For…
Read moreStatistical interaction modeling in non-linear mixed effect models: a case study in neonatal pharmacology
Thursday 16 October, 2025
Introduction Covariate analysis is a crucial step in nonlinear mixed-effects (NLME) modeling to enable individualized dose and treatment optimization. Covariates…
Read moreHierarchical group LASSO with random effects: identification of high-dimensional omics-drug interactions predictive of treatment response in patient-derived tumor growth data
Thursday 16 October, 2025
Objectives: High-dimensional molecular profiling technologies (‘omics’) including genomics and transcriptomics are rapidly emerging as promising approach to personalize drug treatments….
Read moreUse of item-based non-linear mixed effects model to improve confidence in Phase III clinical trial decision-making
Thursday 16 October, 2025
Introduction: The proportion of failed trials due to lack of efficacy is strikingly greater in Phase III clinical drug development…
Read moreExtended model-based meta-analysis of joint longitudinal FEV1 and exacerbation rate in randomized COPD trials
Thursday 16 October, 2025
Introduction/Objectives: Parametric Model-Based Meta-Analysis (MBMA) is a quantitative approach that integrates relevant aggregate data (AD) from published randomized clinical trials…
Read moreAssociation between tumor size kinetics and survival in advanced urothelial carcinoma patients treated with atezolizumab: implication for patient’s follow-up
Thursday 16 October, 2025
Context: Immune-oncology is revolutionizing cancer treatment, but the association between treatment response and survival remains poorly understood. The response kinetics,…
Read moreModelling approaches to support tusamitamab ravtansine (DM4 anti-CEACAM5 antibody-drug conjugate) drug development.
Thursday 16 October, 2025
Objectives: Carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) is a cell-surface glycoprotein highly expressed in several tumor types. Tusamitamab ravtansine…
Read moreIntegrated multiple analytes and semi-mechanistic population pharmacokinetic model of tusamitamab ravtansine, a DM4 anti-CEACAM5 antibody-drug conjugate.
Thursday 16 October, 2025
Introduction: Carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) is a cell-surface glycoprotein highly expressed in several tumor types [1]. Tusamitamab…
Read morePopulation Pharmacokinetic Analysis for Novel Acid Pump Antagonist DWP14012
Thursday 16 October, 2025
Objectives: DWP14012 is a novel potassium-competitive acid blocker, which reversibly binds to H+, K+-ATPase without acid activation [1]. As expected…
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