Dealing with global safety issues : was the response to QT-liability of non-cardiac drugs well coordinated?
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Top-down, Bottom-up and Middle-out Strategies for Drug Cardiac Safety Assessment via Modeling and SimulationsComputer-based prediction of the drug proarrhythmic effect: problems, issues, known and suspected challengesDrug-induced liver injury: Towards early prediction and risk stratificationElectrocardiographic Biomarkers for Detection of Drug-Induced Late Sodium Current BlockAutomated Algorithm for J-Tpeak and Tpeak-Tend Assessment of Drug-Induced Proarrhythmia RiskLate sodium current block for drug-induced long QT syndrome: Results from a prospective clinical trialModel of the distribution of diastolic left ventricular posterior wall thickness in healthy adults and its impact on the behavior of a string of virtual cardiomyocytes.A new classifier-based strategy for in-silico ion-channel cardiac drug safety assessment.Moxifloxacin-induced QTc interval prolongations in healthy male Japanese and Caucasian volunteers: a direct comparison in a thorough QT study.Comprehensive T wave morphology assessment in a randomized clinical study of dofetilide, quinidine, ranolazine, and verapamilQT prolongation and torsades de pointes with psychotropic agentsThe Contribution of National Spontaneous Reporting Systems to Detect Signals of Torsadogenicity: Issues Emerging from the ARITMO Project.Detecting moxifloxacin-induced QTc prolongation in thorough QT and early clinical phase studies using a highly automated ECG analysis approachWhat can nanosafety learn from drug development? The feasibility of "safety by design".Human ex-vivo action potential model for pro-arrhythmia risk assessment.Are ECG monitoring recommendations before prescription of QT-prolonging drugs applied in daily practice? The example of haloperidol.Quantitative Comparison of Effects of Dofetilide, Sotalol, Quinidine, and Verapamil between Human Ex vivo Trabeculae and In silico Ventricular Models Incorporating Inter-Individual Action Potential Variability.Early Drug Discovery Prediction of Proarrhythmia Potential and Its CovariatesReplacing the thorough QT study: reflections of a baby in the bath water.hiPSC-CM Monolayer Maturation State Determines Drug Responsiveness in High Throughput Pro-Arrhythmia ScreenThe thorough QT study: Is its demise on the horizon?Mechanistic Model-Informed Proarrhythmic Risk Assessment of Drugs: Review of the "CiPA" Initiative and Design of a Prospective Clinical Validation Study.Necessity to evaluate PI3K/Akt signalling pathway in proarrhythmia.Nonclinical cardiovascular safety of pitolisant: comparing International Conference on Harmonization S7B and Comprehensive in vitro Pro-arrhythmia Assay initiative studies.Development of models for predicting Torsade de Pointes cardiac arrhythmias using perceptron neural networks.Comparison of Two Highly Automated ECG Algorithms for Detection of Drug-Induced Cardiac Ion Channel Block.Balancing the Need for Personalization of QT Correction and Generalization of Study Results: Going Beyond Thorough QT Studies.Drug-Induced Arrhythmia: Bridging the Gap Between Pathophysiological Knowledge and Clinical Practice.Enabling robust assessment of QTc prolongation in early phase clinical trials.Early afterdepolarisation tendency as a simulated pro-arrhythmic risk indicator† †Electronic supplementary information (ESI) available. See DOI: 10.1039/C7TX00141J.Early afterdepolarisation tendency as a simulated pro-arrhythmic risk indicator.Comprehensive Translational Assessment of Human-Induced Pluripotent Stem Cell Derived Cardiomyocytes for Evaluating Drug-Induced Arrhythmias.Translating New Science Into the Drug Review Process: The US FDA's Division of Applied Regulatory Science.Analysis of an ECG record database reveals QT interval prolongation potential of famotidine in a large Korean population.Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14.Differentiating drug-induced multichannel block on the electrocardiogram: randomized study of dofetilide, quinidine, ranolazine, and verapamil.Improving the assessment of heart toxicity for all new drugs through translational regulatory science.Quantitative approach for cardiac risk assessment and interpretation in tuberculosis drug development.Withdrawal of prenylamine: perspectives on pharmacological, clinical and regulatory outcomes following the first QT-related casualtyInternational Multisite Study of Human-Induced Pluripotent Stem Cell-Derived Cardiomyocytes for Drug Proarrhythmic Potential Assessment
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Dealing with global safety issues : was the response to QT-liability of non-cardiac drugs well coordinated?
description
article científic
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article scientifique
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articol științific
@ro
articolo scientifico
@it
artigo científico
@gl
artigo científico
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artigo científico
@pt-br
artikel ilmiah
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artikull shkencor
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artículo científico
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name
Dealing with global safety iss ...... ardiac drugs well coordinated?
@en
type
label
Dealing with global safety iss ...... ardiac drugs well coordinated?
@en
prefLabel
Dealing with global safety iss ...... ardiac drugs well coordinated?
@en
P2093
P2860
P1433
P1476
Dealing with global safety iss ...... ardiac drugs well coordinated?
@en
P2093
Joel Morganroth
Norman Stockbridge
Rashmi R Shah
P2860
P2888
P304
P356
10.1007/S40264-013-0016-Z
P577
2013-03-01T00:00:00Z
P6179
1047599740