Detection of QTc Effects in Small Studies-Implications for Replacing the Thorough QT Study
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Title
Detection of QTc Effects in Small Studies-Implications for Replacing the Thorough QT Study
Authors
Keywords
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Journal
ANNALS OF NONINVASIVE ELECTROCARDIOLOGY
Volume 20, Issue 4, Pages 368-377
Publisher
Wiley
Online
2014-11-04
DOI
10.1111/anec.12227
References
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Related references
Note: Only part of the references are listed.- Cardiac Safety Research Consortium: Can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward
- (2014) Borje Darpo et al. AMERICAN HEART JOURNAL
- Effect of lenvatinib (E7080) on the QTc interval: results from a thorough QT study in healthy volunteers
- (2014) Robert C. Shumaker et al. CANCER CHEMOTHERAPY AND PHARMACOLOGY
- Concentration-effect modeling based on change from baseline to assess the prolonging effect of drugs on QTc together with an estimate of the circadian time course
- (2014) Georg Ferber et al. JOURNAL OF CLINICAL PHARMACOLOGY
- Lomitapide at Supratherapeutic Plasma Levels Does Not Prolong the QTc Interval-Results from a TQT Study with Moxifloxacin and Ketoconazole
- (2013) Borje Darpo 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
- Planning and Executing Response-Adaptive Learn-Phase Clinical Trials: 1. The Process
- (2012) Parvin Fardipour et al. DRUG INFORMATION JOURNAL
- 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
- Considerations for Clinical Trial Design and Data Analyses of Thorough QT Studies Using Drug-Drug Interaction
- (2010) Hao Zhu et al. JOURNAL OF CLINICAL PHARMACOLOGY
- The thorough QT/QTc study 4 years after the implementation of the ICH E14 guidance
- (2009) B Darpo BRITISH JOURNAL OF 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 Including Design and Sample Size Calculation in Thorough QT/QTc Studies∗
- (2008) Joanne Zhang et al. Journal of Biopharmaceutical Statistics
- Design of the “Thorough QT Study”
- (2007) B Darpo et al. CLINICAL PHARMACOLOGY & THERAPEUTICS
- 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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