Assessing proarrhythmic potential of drugs when optimal studies are infeasible.
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Update on the evaluation of a new drug for effects on cardiac repolarization in humans: issues in early drug developmentTowards a better understanding of QT interval variabilityEarly QT assessment--how can our confidence in the data be improved?Romidepsin: a new therapy for cutaneous T-cell lymphoma and a potential therapy for solid tumors.The thorough QT/QTc study 4 years after the implementation of the ICH E14 guidance.Prolonged QTc interval in cancer therapeutic drug development: defining arrhythmic risk in malignancy.Electrocardiographic effects of class 1 selective histone deacetylase inhibitor romidepsin.Exposure-response analysis of pertuzumab in HER2-positive metastatic breast cancer: absence of effect on QTc prolongation and other ECG parameters.Effect of veliparib (ABT-888) on cardiac repolarization in patients with advanced solid tumors: a randomized, placebo-controlled crossover study.Assessing blood pressure responses to noncardiovascular drugs: the beneficial role of ambulatory blood pressure monitoring.Dealing with global safety issues : was the response to QT-liability of non-cardiac drugs well coordinated?Cardiovascular safety of tyrosine kinase inhibitors: with a special focus on cardiac repolarisation (QT interval).Optimizing oncology therapeutics through quantitative translational and clinical pharmacology: challenges and opportunities.hERG1 potassium channel in cancer cells: a tool to reprogram immortality.Effects of Trastuzumab Emtansine (T-DM1) on QT Interval and Safety of Pertuzumab Plus T-DM1 in Patients With Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer.An open-label study to investigate the cardiac safety profile of cabazitaxel in patients with advanced solid tumors.Evaluation of the potential for QTc prolongation in patients with solid tumors receiving nivolumab.Effect of axitinib on the QT interval in healthy volunteers.Onartuzumab with or without bevacizumab in combination with weekly paclitaxel does not prolong QTc or adversely affect other ECG parameters in patients with locally recurrent or metastatic triple-negative breast cancer.Drugs and life-threatening ventricular arrhythmia risk: results from the DARE study cohort.Effect of small angiokinase inhibitor nintedanib (BIBF 1120) on QT interval in patients with previously untreated, advanced renal cell cancer in an open-label, phase II study.Modelling of drug-induced QT-interval prolongation: estimation approaches and translational opportunities.Effect of alisertib, an investigational aurora a kinase inhibitor on the QTc interval in patients with advanced malignancies.Phase II, open-label trial to assess QTcF effects, pharmacokinetics and antitumor activity of afatinib in patients with relapsed or refractory solid tumors.A phase I, open-label, single-arm study for QT assessment of eribulin mesylate in patients with advanced solid tumors.Strategic and Statistical Considerations on the QT Assessment of Volasertib.Cardiovascular Safety in Drug Development: A Role for Endothelial Function Tests.A Quantitative Framework to Evaluate Proarrhythmic Risk in a First-in-Human Study to Support Waiver of a Thorough QT Study.The Role of Public-Private Partnerships in Catalyzing the Critical Path.
P2860
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P2860
Assessing proarrhythmic potential of drugs when optimal studies are infeasible.
description
article científic
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article scientifique
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articolo scientifico
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artigo científico
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bilimsel makale
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scientific article published on May 2009
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vedecký článok
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vetenskaplig artikel
@sv
videnskabelig artikel
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vědecký článek
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name
Assessing proarrhythmic potential of drugs when optimal studies are infeasible.
@en
Assessing proarrhythmic potential of drugs when optimal studies are infeasible.
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type
label
Assessing proarrhythmic potential of drugs when optimal studies are infeasible.
@en
Assessing proarrhythmic potential of drugs when optimal studies are infeasible.
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prefLabel
Assessing proarrhythmic potential of drugs when optimal studies are infeasible.
@en
Assessing proarrhythmic potential of drugs when optimal studies are infeasible.
@nl
P2093
P1476
Assessing proarrhythmic potential of drugs when optimal studies are infeasible
@en
P2093
Brian P Booth
Colette Strnadova
Edwin P Rock
Howard J Fingert
Ignacio Rodriguez
John Finkle
Kathleen Uhl
Norman Stockbridge
Peter R Kowey
Richard J Kovacs
P304
827-36, 836.e1
P356
10.1016/J.AHJ.2009.02.020
P407
P577
2009-05-01T00:00:00Z