Objectives: To develop a statistically sound approach for PK-QT analysis when jointly modeling the impact of two active compounds, and…
Read morePoster: Drug/Disease Modelling - Safety
Translational in-vitro in-vivo model to correlate HIPS derived cardiomyocyte contractility assay and in-vivo dog telemetry based dPdtmax measurements
Objectives: Cardiovascular safety is one of the most frequent causes of safety related attrition both pre-clinically and clinically. Limited progress has…
Read moreRepeated time-to-events model of Nausea and Vomiting induced by Efpeglenatide
Introduction: Obesity has become an increasingly prevalent condition in modern society, significantly impacting both health and overall quality of life….
Read moreOptimizing Imatinib Dosing in Pulmonary Arterial Hypertension: A Repeated Time-to-Event Modeling Approach to Assess Safety
Introduction: Pulmonary arterial hypertension (PAH) is a rare and progressive disease marked by increased mean pulmonary artery pressure, often leading…
Read moreLeading with Excellence: The Impact of Model-Based QT Assessment in Drug Development.
Objectives All drugs with systemic bioavailability require assessment of the QT interval, which represents ventricular depolarization and repolarization activity of…
Read moreCharacterization of paroxetine pharmacokinetics during the perinatal period
Introduction/Objectives: Paroxetine is a selective serotonin reuptake inhibitor commonly used to treat mental health conditions, including in pregnant and breastfeeding…
Read moreThe Effect of Insulin, GLP-1 and GIP Receptor Agonists, and Sodium-Glucose Cotransporter 2 Inhibitor on Major Adverse Cardiovascular Events in Diabetic Patients
Introduction: Cardiovascular diseases (CVDs) are of the most common complications for individuals with diabetes, reflecting a complex interplay between risk…
Read moreComparison of different minimal continuous-time Markov model (mCTMM) structures for the analysis of symptom burden during anti-cancer drug therapy
Introduction: Adverse drug events (ADE) represent a great burden for patients in the treatment with antitumor drugs and can in…
Read moreModel Informed Assessment of QT prolongation during drug development: A Three-Year Retrospective Analysis of EMA Scientific Advices
Introduction: The assessment of proarrhythmic risk associated with QT interval prolongation and Torsade de Pointes (TdP) is a regulatory requirement…
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