Thursday 16 October, 2025
Objectives: To evaluate the sex effects on the potential risk of significant QT prolongation using a physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD)…
Read morePoster: Safety (e.g. QT prolongation)
Characterization of the Occurrence, Severity, and Duration of Immune-Related Adverse Events (irAEs) in Advanced Melanoma Patients Treated with Ipilimumab
Thursday 16 October, 2025
Objectives: Ipilimumab is a fully human monoclonal antibody directed against cytotoxic T-lymphocyte antigen-4 (CTLA-4) that is being developed as a…
Read moreModel-based QTc interval risk assessment in Phase 1 studies and its impact on the drug development trajectory
Thursday 16 October, 2025
Objectives: Population C-QTc analysis is useful tool to leverage QTc data from Phase I studies. We present the results of…
Read morePopulation PKPD Modeling of Milnacipran Effect on Blood Pressure and Heart Rate Over 24-Hour Period Using Ambulatory Blood Pressure Monitoring in Normotensive and Hypertensive Patients With Fibromyalgia
Thursday 16 October, 2025
Objectives: To develop population PKPD models describing the relationship between milnacipran (MLN) and ambulatory blood pressure (BP) and heart rate…
Read moreProbability-Based Risk Assessment of QT Prolongation in Early Phase Drug Development
Thursday 16 October, 2025
Objectives: Drugs A and B are structurally similar molecules in Phase I development for the treatment of conditions associated with delayed…
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