Early QT assessment--how can our confidence in the data be improved?
about
The role of concentration-effect relationships in the assessment of QTc interval prolongationConcentration-Response Modeling of ECG Data From Early-Phase Clinical Studies as an Alternative Clinical and Regulatory Approach to Assessing QT Risk - Experience From the Development Program of Lemborexant.Evaluating the Use of Linear Mixed-Effect Models for Inference of the Concentration-QTc Slope Estimate as a Surrogate for a Biological QTc Model.Safety, pharmacokinetics, pharmacogenomics and QT concentration-effect modelling of the SirT1 inhibitor selisistat in healthy volunteersEvaluation of the QT effect of a combination of piperaquine and a novel anti-malarial drug candidate OZ439, for the treatment of uncomplicated malaria.The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".Population pharmacokinetics and electrocardiographic effects of dihydroartemisinin-piperaquine in healthy volunteers.Estimation of QT interval prolongation through model-averaging.Comparing QT interval variability of semiautomated and high-precision ECG methodologies in seven thorough QT studies-implications for the power of studies intended for definitive evaluation of a drug's QT effect.Comparison of Digital 12-Lead ECG and Digital 12-Lead Holter ECG Recordings in Healthy Male Subjects: Results from a Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.Can Bias Evaluation Provide Protection Against False-Negative Results in QT Studies Without a Positive Control Using Exposure-Response Analysis?The Power of Phase I Studies to Detect Clinical Relevant QTc Prolongation: A Resampling Simulation Study.Replacing the thorough QT study: reflections of a baby in the bath water.The thorough QT study: Is its demise on the horizon?Nonclinical cardiovascular safety of pitolisant: comparing International Conference on Harmonization S7B and Comprehensive in vitro Pro-arrhythmia Assay initiative studies.Enabling robust assessment of QTc prolongation in early phase clinical trials.Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase.A Quantitative Framework to Evaluate Proarrhythmic Risk in a First-in-Human Study to Support Waiver of a Thorough QT Study.Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14.
P2860
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P2860
Early QT assessment--how can our confidence in the data be improved?
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2013 nî lūn-bûn
@nan
2013 թուականի Նոյեմբերին հրատարակուած գիտական յօդուած
@hyw
2013 թվականի նոյեմբերին հրատարակված գիտական հոդված
@hy
2013年の論文
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2013年論文
@yue
2013年論文
@zh-hant
2013年論文
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2013年論文
@zh-mo
2013年論文
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2013年论文
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Early QT assessment--how can our confidence in the data be improved?
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Early QT assessment--how can our confidence in the data be improved?
@en
Early QT assessment--how can our confidence in the data be improved?
@nl
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Early QT assessment--how can our confidence in the data be improved?
@ast
Early QT assessment--how can our confidence in the data be improved?
@en
Early QT assessment--how can our confidence in the data be improved?
@nl
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Early QT assessment--how can our confidence in the data be improved?
@ast
Early QT assessment--how can our confidence in the data be improved?
@en
Early QT assessment--how can our confidence in the data be improved?
@nl
P2860
P356
P1476
Early QT assessment--how can our confidence in the data be improved?
@en
P2093
Borje Darpo
P2860
P356
10.1111/BCP.12068
P407
P577
2013-11-01T00:00:00Z