The IQ-CSRC Prospective Clinical Phase 1 Study: “Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?”

Early Investigation of QTc Liability

(2013) Rashmi R. Shah et al.   DRUG SAFETY

The impact of drug-related QT prolongation on FDA regulatory decisions

(2013) Eunjung Park et al.   INTERNATIONAL JOURNAL OF CARDIOLOGY

Early QT assessment - how can our confidence in the data be improved?

(2012) Borje Darpo et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Exenatide at therapeutic and supratherapeutic concentrations does not prolong the QTcinterval in healthy subjects

(2012) Börje Darpö 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

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

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