Related references
Note: Only part of the references are listed.Stability of the Effect of a Standardized Meal on QTc
Jorg Taubel et al.
ANNALS OF NONINVASIVE ELECTROCARDIOLOGY (2017)
Can Bias Evaluation Provide Protection Against False-Negative Results in QT Studies Without a Positive Control Using Exposure-Response Analysis?
Georg Ferber et al.
JOURNAL OF CLINICAL PHARMACOLOGY (2017)
Enabling robust assessment of QTc prolongation in early phase clinical trials
Devan V. Mehrotra et al.
PHARMACEUTICAL STATISTICS (2017)
Late sodium current block for drug-induced long QT syndrome: Results from a prospective clinical trial
L. Johannesen et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2016)
Operational Characteristics of Linear Concentration-QT Models for Assessing QTc Interval in the Thorough QT and Phase I Clinical Studies
C. Garnett et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2016)
Concentration-QT analysis of the randomized, placebo- and moxifloxacin-controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects
Rashmi Mehta et al.
JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS (2016)
Modelling PK/QT relationships from Phase I dose-escalation trials for drug combinations and developing quantitative risk assessments of clinically relevant QT prolongations
Karen Sinclair et al.
PHARMACEUTICAL STATISTICS (2016)
Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation
S. F. Marshall et al.
CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY (2016)
A Quantitative Framework to Evaluate Proarrhythmic Risk in a First-in-Human Study to Support Waiver of a Thorough QT Study
C. H. Nelson et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2015)
Results From the IQ-CSRC Prospective Study Support Replacement of the Thorough QT Study by QT Assessment in the Early Clinical Phase
B. Darpo et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2015)
Establishing assay sensitivity in QT studies: experience with the use of moxifloxacin in an early phase clinical pharmacology study and comparison with its effect in a thorough QT study
Rashmi R. Shah et al.
EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY (2015)
The reproducibility of QTc changes after meal intake
Jorg Taubel
JOURNAL OF ELECTROCARDIOLOGY (2015)
The Power of Phase I Studies to Detect Clinical Relevant QTc Prolongation: A Resampling Simulation Study
Georg Ferber et al.
BIOMED RESEARCH INTERNATIONAL (2015)
Detection of QTc Effects in Small StudiesImplications for Replacing the Thorough QT Study
Georg Ferber et al.
ANNALS OF NONINVASIVE ELECTROCARDIOLOGY (2015)
The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?
Borje Darpo et al.
ANNALS OF NONINVASIVE ELECTROCARDIOLOGY (2014)
Differentiating Drug-Induced Multichannel Block on the Electrocardiogram: Randomized Study of Dofetilide, Quinidine, Ranolazine, and Verapamil
L. Johannesen et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2014)
Test Hysteresis in Pharmacokinetic/Pharmacodynamic Relationship with Mixed-Effect Models: An Instrumental Model Approach
Jixian Wang et al.
JOURNAL OF BIOPHARMACEUTICAL STATISTICS (2014)
Insulin at normal physiological levels does not prolong QTc interval in thorough QT studies performed in healthy volunteers
Jorg Taubel et al.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2013)
Baseline Correction in Parallel Thorough QT Studies
Joanne Zhang et al.
DRUG SAFETY (2013)
The effects of active metabolites on parameter estimation in linear mixed effect models of concentration-QT analyses
Peter L. Bonate
JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS (2013)
Effect of assay measurement error on parameter estimation in concentrationQTc interval modeling
Peter L. Bonate
PHARMACEUTICAL STATISTICS (2013)
Methodologies to characterize the QT/corrected QT interval in the presence of drug-induced heart rate changes or other autonomic effects
Christine E. Garnett et al.
AMERICAN HEART JOURNAL (2012)
DELAYED EFFECTS IN THE EXPOSURE-RESPONSE ANALYSIS OF CLINICAL QTc TRIALS
Patricia Glomb et al.
JOURNAL OF BIOPHARMACEUTICAL STATISTICS (2012)
Shortening of the QT Interval After Food Can Be Used to Demonstrate Assay Sensitivity in Thorough QT Studies
Jorg Taubel et al.
JOURNAL OF CLINICAL PHARMACOLOGY (2012)
Creation of a Knowledge Management System for QT Analyses
Christoffer W. Tornoe et al.
JOURNAL OF CLINICAL PHARMACOLOGY (2011)
Considerations for Clinical Trial Design and Data Analyses of Thorough QT Studies Using Drug-Drug Interaction
Hao Zhu et al.
JOURNAL OF CLINICAL PHARMACOLOGY (2010)
Challenges of characterizing proarrhythmic risk due to QTc prolongation induced by nonadjuvant anticancer agents
Nenad Sarapa et al.
EXPERT OPINION ON DRUG SAFETY (2008)
Testing for positive control activity in a thorough QTc study
Joanne Zhang
JOURNAL OF BIOPHARMACEUTICAL STATISTICS (2008)
Statistical issues including design and sample size calculation in thorough QT/QTc studies
Joanne Zhang et al.
JOURNAL OF BIOPHARMACEUTICAL STATISTICS (2008)
Near-thorough QT study as part of a first-in-man study
Marek Malik et al.
JOURNAL OF CLINICAL PHARMACOLOGY (2008)
Application of pharmacokinetic-pharmacodynamic modelling in management of QT abnormalities after citalopram overdose
Geoffrey K. Isbister et al.
INTENSIVE CARE MEDICINE (2006)
Differences between study-specific and subject-specific heart rate corrections of the QT interval in investigations of drug induced QTc prolongation
M Malik et al.
PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY (2004)
Share Paper
