Results From the IQ-CSRC Prospective Study Support Replacement of the Thorough QT Study by QT Assessment in the Early Clinical Phase

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