Results From the IQ-CSRC Prospective Study Support Replacement of the Thorough QT Study by QT Assessment in the Early Clinical Phase
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Title
Results From the IQ-CSRC Prospective Study Support Replacement of the Thorough QT Study by QT Assessment in the Early Clinical Phase
Authors
Keywords
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Journal
CLINICAL PHARMACOLOGY & THERAPEUTICS
Volume 97, Issue 4, Pages 326-335
Publisher
Wiley
Online
2015-03-17
DOI
10.1002/cpt.60
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Related references
Note: Only part of the references are listed.- Detection of QTc Effects in Small Studies-Implications for Replacing the Thorough QT Study
- (2014) Georg Ferber et al. ANNALS OF NONINVASIVE ELECTROCARDIOLOGY
- The IQ-CSRC Prospective Clinical Phase 1 Study: “Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?”
- (2013) Borje Darpo et al. ANNALS OF NONINVASIVE ELECTROCARDIOLOGY
- Early Investigation of QTc Liability
- (2013) Rashmi R. Shah et al. DRUG SAFETY
- Early QT assessment - how can our confidence in the data be improved?
- (2012) Borje Darpo et al. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
- The cardiac safety research consortium ECG database
- (2012) Paul Kligfield et al. JOURNAL OF ELECTROCARDIOLOGY
- The Cost-Effectiveness of Drug Regulation: The Example of Thorough QT/QTc Studies
- (2011) J C Bouvy et al. CLINICAL PHARMACOLOGY & THERAPEUTICS
- Population Pharmacokinetic and Concentration-QTc Models for Moxifloxacin: Pooled Analysis of 20 Thorough QT Studies
- (2011) Jeffry A. Florian et al. JOURNAL OF CLINICAL PHARMACOLOGY
- The Cardiac Safety Research Consortium electrocardiogram warehouse: Thorough QT database specifications and principles of use for algorithm development and testing
- (2010) Paul Kligfield et al. AMERICAN HEART JOURNAL
- Letter to the Editor: Statistical Issues of QT Prolongation Assessment Based on Linear Concentration Modeling by Yi Tsong et al.
- (2010) Yaning Wang et al. Journal of Biopharmaceutical Statistics
- Creation of a Knowledge Management System for QT Analyses
- (2010) Christoffer W. Tornøe et al. JOURNAL OF CLINICAL PHARMACOLOGY
- Is a Thorough QTc Study Necessary? The Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs
- (2009) Shashank Rohatagi et al. JOURNAL OF CLINICAL PHARMACOLOGY
- Statistical Issues of QT Prolongation Assessment Based on Linear Concentration Modeling∗
- (2008) Yi Tsong et al. Journal of Biopharmaceutical Statistics
- Statistical Issues Including Design and Sample Size Calculation in Thorough QT/QTc Studies∗
- (2008) Joanne Zhang et al. Journal of Biopharmaceutical Statistics
- Near-Thorough QT Study as Part of a First-In-Man Study
- (2008) Marek Malik et al. JOURNAL OF CLINICAL PHARMACOLOGY
- Concentration-QT Relationships Play a Key Role in the Evaluation of Proarrhythmic Risk During Regulatory Review
- (2007) Christin E. Garnett et al. JOURNAL OF CLINICAL PHARMACOLOGY
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