Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14

Safety, pharmacokinetics, pharmacogenomics and QT concentration−effect modelling of the SirT1 inhibitor selisistat in healthy volunteers

(2015) Goran Westerberg et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

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

Detection of QTc Effects in Small Studies-Implications for Replacing the Thorough QT Study

(2014) Georg Ferber et al.   ANNALS OF NONINVASIVE ELECTROCARDIOLOGY

Electrocardiographic Data Quality in Thorough QT/QTc Studies

(2014) Lars Johannesen et al.   DRUG SAFETY

Rechanneling the cardiac proarrhythmia safety paradigm: A meeting report from the Cardiac Safety Research Consortium

(2013) Philip T. Sager et al.   AMERICAN HEART JOURNAL

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

Dealing with Global Safety Issues

(2013) Norman Stockbridge 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

A Modeling and Simulation Approach to Characterize Methadone QT Prolongation Using Pooled Data From Five Clinical Trials in MMT Patients

(2012) J Florian et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Thorough QT Studies and Indirect Causes of QTc Changes

(2012) MAREK MALIK et al.   PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY

The Cost-Effectiveness of Drug Regulation: The Example of Thorough QT/QTc Studies

(2011) J C Bouvy et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Assessing electrocardiographic data quality and possible replacement of pharmacologic positive control in thorough QT/QTc studies by investigations of drug-free QTc stability

(2011) Marek Malik et al.   HEART RHYTHM

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

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 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