Objectives: More than 40 years after rifampicin’s discovery, bedaquiline (BDQ) was the first anti-tuberculosis drug with a novel mechanism of…
Read morePoster: Drug/Disease Modelling - Safety
Simulation of pharmacokinetics of amitriptyline and nortriptyline and their common effect on human cardiac electrophysiology in healthy population
Objectives: In assessing drug triggered cardiac effect the parent drug and its metabolites’ exposure in cardiac tissue seems to be of…
Read moreDeciphering the mechanisms of drug effects on cardiovascular system through semi-mechanistic modeling of preclinical telemetry data: a validation study
Objectives: Predicting potential drug-induced unintended effects on the cardiovascular (CV) system remains a critical component of drug discovery process. To…
Read morePopulation concentration-QT-modelling of CHF6001 following dry powder inhalation in healthy volunteers.
Objectives: CHF6001 is a potent and selective phosphodiesterase-4 (PDE-4) inhibitor currently under development for treatment of chronic obstructive pulmonary disease…
Read morePhysiologically based pharmacokinetic model (PBPK) for the halofantrine cardiac effect prediction – proof of concept study towards the system for the antimalarial drugs cardiac safety assessment.
Objectives: Antimalarial drugs help to cure the disease yet carry serious safety problems at least some of them are connected with…
Read morePrediction of escitalopram exposure in infants through breastfeeding by modeling and simulation
Objectives: Worldwide about 10% of pregnant women and women who have just given birth experience a mental disorder, primarily depression….
Read moreTolerance modeling: effects of the selective S1P1 receptor modulator ponesimod on heart rate
Objectives: Development of a population pharmacokinetic/pharmacodynamic (PK/PD) model to characterize the effect of the selective S1P1 receptor modulator ponesimod on heart…
Read morePharmacokinetic/Pharmacodynamic Modelling of Recurrent Adverse Events as Function of Drug Concentration and Time
Objectives: To develop a PK/PD model for recurrent adverse events (AE) and perform simulations to predict the incidence of AE…
Read moreHypoglycemic risk kinetics modeling as patient achieving glucose control in insulin-naïve T2DM patients initiating glargine 300U/mL versus glargine 100U/mL
Objectives: The Edition 3 (NCT01676220)was a multicenter, randomized, open-label, two-arm parallel-group Phase 3 study comparing the safety of efficacy of glargine…
Read moreExposure Response Analysis of the Effect of Loperamide on the Cardiac Repolarization Interval in Healthy Adult Subjects
Introduction and Objectives: Loperamide is indicated for the symptomatic control of acute and chronic diarrhea via selective binding and activation of…
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