Objectives: Assess the QT interval prolonging effect at supra-therapeutic exposure of a new molecular entity (NME) using a DDI study. Methods: A…
Read morePoster: Drug/Disease modeling - Safety
Development of QT prolongation model in guinea pig with hERG assay-in vivo PK- in-vivo QT effect to guide decision making in early drug discovery
Objectives: hERG assay is a one of traditional approaches for evaluating cardiac safety of drug in early drug discovery [1]….
Read moreModelling and simulation of adverse drug effects on heart rate in the anaesthetized mouse
Objectives: To develop a PK/PD model of adverse, drug-mediated increase in heart rate in the anaesthetized mouse in order to…
Read moreToxicity assessment via drug-drug interaction modeling for trabectedin in patients with advanced malignancies
Objectives:Trabectedin is a DNA minor groove binder, marketed in Europe for treating soft tissue sarcomas and, in combination with liposomal…
Read moreEmpagliflozin as Adjunct to Insulin in Patients with Type 1 Diabetes Mellitus: Modelling Rate and Severity of Hypoglycemic Events
Objectives: Due to its insulin-independent mechanism of action, empagliflozin is under clinical investigation as adjunct to insulin to improve glycemic…
Read morePopulation PKPD modelling of QRS and PR intervals in conscious dogs.
Objectives: To develop population PKPD models for describing baseline and drug-induced changes in QRS and PR intervals in dogs using standard…
Read morePopulation PKPD modeling of moxifloxacin effect on QT interval prolongation from baseline in Korean and Japanese healthy male and female subjects
Objectives: To develop population PKPD models describing the relationship between moxifloxacin and corrected QT interval prolongation in Korean and Japanese. Methods: Population…
Read morePopulation Pharmacokinetic/Pharmacoynamic Models to evaluate the positive and delayed effect of escitalopram on QT prolongation
Objectives: Escitalopram had potential to prolong QT interval in dose-dependent manner and to show delayed QT interval prolongation [1]. To…
Read morePreclinical cardiovascular risk assessment of PPAR-gamma agonist effects based on translational PK/PD modelling
Objectives: Safety margin assessments due to PPAR-gamma activity in toxicological studies is often confounded by study length and species sensitivity…
Read moreA Joint Concentration-Response Model for ABPM Measurements of Systolic and Diastolic Blood Pressure
Objectives: To characterize the relationship between the concentration of an experimental drug, LY, and ambulatory blood pressure monitoring (ABPM) measurements of…
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