标题
Scientific white paper on concentration-QTc modeling
作者
关键词
Concentration-QTc model, ICH E14, Thorough QT (TQT) study, Pharmacokinetics/pharmacodynamics
出版物
JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS
Volume 45, Issue 3, Pages 383-397
出版商
Springer Nature
发表日期
2017-12-05
DOI
10.1007/s10928-017-9558-5
参考文献
相关参考文献
注意:仅列出部分参考文献,下载原文获取全部文献信息。- Enabling robust assessment of QTc prolongation in early phase clinical trials
- (2017) Devan V. Mehrotra et al. PHARMACEUTICAL STATISTICS
- Stability of the Effect of a Standardized Meal on QTc
- (2016) Jörg Täubel et al. ANNALS OF NONINVASIVE ELECTROCARDIOLOGY
- Operational Characteristics of Linear Concentration-QT Models for Assessing QTc Interval in the Thorough QT and Phase I Clinical Studies
- (2016) C Garnett et al. CLINICAL PHARMACOLOGY & THERAPEUTICS
- Can Bias Evaluation Provide Protection Against False-Negative Results in QT Studies Without a Positive Control Using Exposure-Response Analysis?
- (2016) Georg Ferber et al. JOURNAL OF CLINICAL PHARMACOLOGY
- Concentration-QT analysis of the randomized, placebo- and moxifloxacin-controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects
- (2016) Rashmi Mehta et al. JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS
- Modelling PK/QT relationships from Phase I dose-escalation trials for drug combinations and developing quantitative risk assessments of clinically relevant QT prolongations
- (2016) Karen Sinclair et al. PHARMACEUTICAL STATISTICS
- A Quantitative Framework to Evaluate Proarrhythmic Risk in a First-in-Human Study to Support Waiver of a Thorough QT Study
- (2015) CH Nelson et al. CLINICAL PHARMACOLOGY & THERAPEUTICS
- Late sodium current block for drug-induced long QT syndrome: Results from a prospective clinical trial
- (2015) L Johannesen et al. CLINICAL PHARMACOLOGY & THERAPEUTICS
- Results From the IQ-CSRC Prospective Study Support Replacement of the Thorough QT Study by QT Assessment in the Early Clinical Phase
- (2015) B Darpo et al. CLINICAL PHARMACOLOGY & THERAPEUTICS
- 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
- (2015) Rashmi R. Shah et al. EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
- The reproducibility of QTc changes after meal intake
- (2015) Jorg Taubel et al. JOURNAL OF ELECTROCARDIOLOGY
- The Power of Phase I Studies to Detect Clinical Relevant QTc Prolongation: A Resampling Simulation Study
- (2015) Georg Ferber et al. Biomed Research International
- Detection of QTc Effects in Small Studies-Implications for Replacing the Thorough QT Study
- (2014) Georg Ferber et al. ANNALS OF NONINVASIVE ELECTROCARDIOLOGY
- Differentiating Drug-Induced Multichannel Block on the Electrocardiogram: Randomized Study of Dofetilide, Quinidine, Ranolazine, and Verapamil
- (2014) L Johannesen et al. CLINICAL PHARMACOLOGY & THERAPEUTICS
- Test Hysteresis in Pharmacokinetic/Pharmacodynamic Relationship with Mixed-Effect Models: An Instrumental Model Approach
- (2014) Jixian Wang et al. Journal of Biopharmaceutical Statistics
- 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
- Baseline Correction in Parallel Thorough QT Studies
- (2013) Joanne Zhang et al. DRUG SAFETY
- The effects of active metabolites on parameter estimation in linear mixed effect models of concentration–QT analyses
- (2013) Peter L. Bonate JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS
- Effect of assay measurement error on parameter estimation in concentration-QTc interval modeling
- (2013) Peter L. Bonate PHARMACEUTICAL STATISTICS
- Methodologies to characterize the QT/corrected QT interval in the presence of drug-induced heart rate changes or other autonomic effects
- (2012) Christine E. Garnett et al. AMERICAN HEART JOURNAL
- Insulin at normal physiological levels does not prolong QTcinterval in thorough QT studies performed in healthy volunteers
- (2012) Jorg Taubel et al. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
- Delayed Effects in the Exposure-Response Analysis of Clinical QTc Trials
- (2012) Patricia Glomb et al. Journal of Biopharmaceutical Statistics
- Shortening of the QT Interval After Food Can Be Used to Demonstrate Assay Sensitivity in Thorough QT Studies
- (2011) Jorg Taubel 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
- Creation of a Knowledge Management System for QT Analyses
- (2010) Christoffer W. Tornøe et al. JOURNAL OF CLINICAL PHARMACOLOGY
- Challenges of characterizing proarrhythmic risk due to QTc prolongation induced by nonadjuvant anticancer agents
- (2008) Nenad Sarapa et al. Expert Opinion On Drug Safety
- Testing for Positive Control Activity in a Thorough QTc Study∗
- (2008) Joanne Zhang 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
Find Funding. Review Successful Grants.
Explore over 25,000 new funding opportunities and over 6,000,000 successful grants.
ExploreCreate your own webinar
Interested in hosting your own webinar? Check the schedule and propose your idea to the Peeref Content Team.
Create Now