Abstracts

The potential of modeling and simulation as support for generic long-acting injectable (LAI) marketing authorization applications

Thursday 16 October, 2025

Introduction Long-acting injectable (LAI) products are formulations intended for prolonged drug release that offer several benefits including improved patient outcomes….

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Modeling tumor growth inhibition in Glioblastoma spheroids after exposure to RC-106, a novel sigma receptors modulator

Thursday 16 October, 2025

Introduction: Glioblastoma (GBM) is an aggressive brain tumor for which there is no effective cure [1,2]. Therefore, there is an…

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Enhancing statistical power in lipid-lowering therapy studies through optimization of the MACE endpoint composition: a model-based meta-analysis approach

Thursday 16 October, 2025

Introduction: Major adverse cardiac events (MACE) are used to assess the efficacy and safety of cholesterol-lowering compounds in late-stage clinical…

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Predicting Progression Free Survival from Measurable Residual Disease (MRD) in Chronic Lymphocytic Leukemia (CLL)

Thursday 16 October, 2025

Introduction/Objectives:  Measurable Residual Disease (MRD) is detectable and often quantifiable remnant cancer cells following treatment. The association between MRD and…

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A case study of applying machine learning to improve non-invasive assessment of fibrosis stage in MASLD

Thursday 16 October, 2025

Introduction Metabolic dysfunction-associated steatohepatitis (MASH), the more severe form of metabolic dysfunction-associated steatotic liver disease (MASLD), is a major cause…

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To quantify the association between tumor dynamics and overall survival across cancers: a Bayesian meta-analysis

Thursday 16 October, 2025

Context: In oncology clinical trials, the primary clinical endpoint is often overall survival (OS), which requires long study duration.  Tumor size…

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Model informed dose projection for SAB-176 using a joint time-to-event modeling approach in high-risk (HR) patients infected with Influenza

Thursday 16 October, 2025

Objectives:  Influenza, a significant global health concern, can causes severe illness, hospitalizations, and death predominantly in high-risk (HR) groups, including…

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Framework for Polyclonal Antibody Drug Development: Integrating Trial Data and Literature Models

Thursday 16 October, 2025

Objectives:  In the pursuit of advancing immunotherapy for immune and autoimmune disorders, SAb has developed fully human, multi-targeted immunoglobulins (IgGs)…

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Characterization of the population dose-exposure-efficacy relationships of vamorolone, a synthetic corticosteroid drug in the treatment of Duchenne Muscular Dystrophy (DMD)

Thursday 16 October, 2025

Objectives:  Vamorolone (Agamree) is a synthetic steroidal drug approved for the treatment of Duchenne Muscular Dystrophy (DMD), a life-threatening genetic…

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Population pharmacokinetic-pharmacodynamic modeling of the iclepertin drug effect on hemoglobin levels

Thursday 16 October, 2025

Introduction: Iclepertin (BI 425809) is a novel, potent and selective glycine transporter-1 (GlyT1) inhibitor currently in Phase III development to…

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