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
Introduction: Glioblastoma (GBM) is an aggressive brain tumor for which there is no effective cure [1,2]. Therefore, there is an…
Read moreEnhancing statistical power in lipid-lowering therapy studies through optimization of the MACE endpoint composition: a model-based meta-analysis approach
Introduction: Major adverse cardiac events (MACE) are used to assess the efficacy and safety of cholesterol-lowering compounds in late-stage clinical…
Read morePredicting Progression Free Survival from Measurable Residual Disease (MRD) in Chronic Lymphocytic Leukemia (CLL)
Introduction/Objectives: Measurable Residual Disease (MRD) is detectable and often quantifiable remnant cancer cells following treatment. The association between MRD and…
Read moreA case study of applying machine learning to improve non-invasive assessment of fibrosis stage in MASLD
Introduction Metabolic dysfunction-associated steatohepatitis (MASH), the more severe form of metabolic dysfunction-associated steatotic liver disease (MASLD), is a major cause…
Read moreTo quantify the association between tumor dynamics and overall survival across cancers: a Bayesian meta-analysis
Context: In oncology clinical trials, the primary clinical endpoint is often overall survival (OS), which requires long study duration. Tumor size…
Read moreModel informed dose projection for SAB-176 using a joint time-to-event modeling approach in high-risk (HR) patients infected with Influenza
Objectives: Influenza, a significant global health concern, can causes severe illness, hospitalizations, and death predominantly in high-risk (HR) groups, including…
Read moreFramework for Polyclonal Antibody Drug Development: Integrating Trial Data and Literature Models
Objectives: In the pursuit of advancing immunotherapy for immune and autoimmune disorders, SAb has developed fully human, multi-targeted immunoglobulins (IgGs)…
Read moreCharacterization of the population dose-exposure-efficacy relationships of vamorolone, a synthetic corticosteroid drug in the treatment of Duchenne Muscular Dystrophy (DMD)
Objectives: Vamorolone (Agamree) is a synthetic steroidal drug approved for the treatment of Duchenne Muscular Dystrophy (DMD), a life-threatening genetic…
Read morePopulation pharmacokinetic-pharmacodynamic modeling of the iclepertin drug effect on hemoglobin levels
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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