Thursday 16 October, 2025
Objectives: Chronopharmacology may play an important role for drugs with narrow therapeutic window particularly for patients predisposed to safety issues…
Read morePoster: Safety (e.g. QT prolongation)
Identifying the translational gap in the evaluation of drug-induced QTc interval prolongation
Thursday 16 October, 2025
Objectives: Assessment of the propensity of new drugs in prolonging QT/QTc interval is critical for the progression of compounds into clinical…
Read moreImpact of delayed effect in Concentration-QT analyses.
Thursday 16 October, 2025
Objectives: In connection with the development of specific statistical methods for the analysis of thorough QT studies, growing attention has…
Read moreA population PK model combined with PK/PD model for analysis of headache in clinical trials
Thursday 16 October, 2025
Objectives: Headache is a common adverse event in clinical studies [1]. The objective of this analysis was to examine the…
Read moreDevelopment of a longitudinal model to describe the QT-time course in healthy volunteers given placebo and moxifloxacin
Thursday 16 October, 2025
Background: ICH Guidance E14 on the evaluation of QT/QTc Interval prolongation for non-antiarrhythmic drugs was endorsed in 2005. Standard statistical…
Read moreComparison of Analysis Methods for Population Exposure-Response in Thorough QT Studies
Thursday 16 October, 2025
Objectives: To compare two approaches for evaluating the relationship between drug concentrations and QTc interval. Methods: Data from two dedicated thorough QT…
Read moreNot-In-Trial Simulations: A tool for mitigating cardiovascular safety risks
Thursday 16 October, 2025
Objectives: QT/QTc-interval prolongation continues to be a concern in drug development today. More effort is needed to explain the discrepancies…
Read morePopulation PK-QT analysis across Phase I studies for a p38 mitogen activated protein kinase inhibitor – PH-797804
Thursday 16 October, 2025
Objectives: The purpose of this analysis was to develop a PK-QT model describing the time-course of QTc interval prolongation following…
Read moreA translational threshold model to assess exposure-driven QTc changes
Thursday 16 October, 2025
Objectives: QT prolongation in the electrocardiogram is a surrogate marker of ‘torsade de pointes' (fatal arrhythmias). This QT parameter is…
Read moreModel-Based Prediction of Domperidone and Ketoconazole Interaction and its Impact on QTc Prolongation
Thursday 16 October, 2025
Objectives: To investigate the application of modelling and simulation in predicting the extent of the increased proarrhythmic potency of domperidone…
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