Update on the evaluation of a new drug for effects on cardiac repolarization in humans: issues in early drug development

Deferasirox does not induce QT/QTc-prolongation in healthy subjects

(2011) R. Sechaud et al.   INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS

Assessing proarrhythmic potential of drugs when optimal studies are infeasible

(2009) Edwin P. Rock et al.   AMERICAN HEART JOURNAL

Randomized, Double-Blind, Crossover Study to Investigate the Effect of Rivaroxaban on QT-Interval Prolongation

(2009) Dagmar Kubitza et al.   DRUG SAFETY

Effects of Standard and Supratherapeutic Doses of Nelfinavir on Cardiac Repolarization: A Thorough QT Study

(2009) Bharat Damle et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Pharmacokinetics and Pharmacodynamic, Pharmacokinetic, Pharmacodynamic, and Electrocardiographic Effects of Dapoxetine and Moxifloxacin Compared With Placebo in Healthy Adult Male Subjects

(2009) Nishit B. Modi et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Subject-specific profiles of QT/RR hysteresis

(2008) Marek Malik et al.   AMERICAN JOURNAL OF PHYSIOLOGY-HEART AND CIRCULATORY PHYSIOLOGY

Etravirine Has No Effect on QT and Corrected QT Interval in HIV-Negative Volunteers

(2008) Monika Peeters et al.   ANNALS OF PHARMACOTHERAPY

Lamotrigine does not prolong QTc in a thorough QT/QTc study in healthy subjects

(2008) Ruth Dixon et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Effect of single doses of maraviroc on the QT/QTc interval in healthy subjects

(2008) John D. Davis et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Predicting QT prolongation in humans during early drug development using hERG inhibition and an anaesthetized guinea-pig model

(2008) X Yao et al.   BRITISH JOURNAL OF PHARMACOLOGY

Strategies to reduce the risk of drug-induced QT interval prolongation: a pharmaceutical company perspective

(2008) C E Pollard et al.   BRITISH JOURNAL OF PHARMACOLOGY

Cellular basis of drug-induced torsades de pointes

(2008) D M Roden   BRITISH JOURNAL OF PHARMACOLOGY

Guide to Receptors and Channels (GRAC), 3rd edition

(2008) S P H Alexander et al.   BRITISH JOURNAL OF PHARMACOLOGY

Thorough QT/QTc Study in Patients With Advanced Parkinson's Disease: Cardiac Safety of Rotigotine

(2008) M Malik et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Effect of levetiracetam on cardiac repolarization in healthy subjects: A single-dose, randomized, placebo- and active-controlled, four-way crossover study

(2008) Réginald Hulhoven et al.   CLINICAL THERAPEUTICS

Effect of brivaracetam on cardiac repolarisation – a thorough QT study

(2008) D. Rosillon et al.   CURRENT MEDICAL RESEARCH AND OPINION

Challenges of characterizing proarrhythmic risk due to QTc prolongation induced by nonadjuvant anticancer agents

(2008) Nenad Sarapa et al.   Expert Opinion On Drug Safety

Keep the QT interval: It is a reliable predictor of ventricular arrhythmias

(2008) Dan M. Roden   HEART RHYTHM

Validation Testing in Thorough QT/QTc Clinical Trials∗

(2008) Yi Tsong et al.   Journal of Biopharmaceutical Statistics

Testing for Positive Control Activity in a Thorough QTc Study∗

(2008) Joanne Zhang   Journal of Biopharmaceutical Statistics

Raltegravir Thorough QT/QTc Study: A Single Supratherapeutic Dose of Raltegravir Does Not Prolong the QTcF Interval

(2008) M. Iwamoto et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Effects of Aliskiren, a Direct Renin Inhibitor, on Cardiac Repolarization and Conduction in Healthy Subjects

(2008) Surya Ayalasomayajula et al.   JOURNAL OF CLINICAL PHARMACOLOGY

T-wave morphology reveals greater effect of d,l-sotalol than QTc

(2008) C. Graff et al.   JOURNAL OF ELECTROCARDIOLOGY

Differences between QT and RR intervals in digital and digitized paper electrocardiograms: contribution of the printer, scanner, and digitization process

(2008) Pooja Hingorani et al.   JOURNAL OF ELECTROCARDIOLOGY

Tp-e/QT ratio as an index of arrhythmogenesis

(2008) Prasad Gupta et al.   JOURNAL OF ELECTROCARDIOLOGY

If a drug deemed ‘safe’ in nonclinical tests subsequently prolongs QT in phase 1 studies, how can its sponsor convince regulators to allow development to proceed?

(2008) Rashmi R. Shah   PHARMACOLOGY & THERAPEUTICS

Early clinical development: Evaluation of drug-induced torsades de pointes risk

(2008) Torbjorn Vik et al.   PHARMACOLOGY & THERAPEUTICS

Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics

(2008) Hugo M. Vargas et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

A quantitative assessment of T-wave morphology in LQT1, LQT2, and healthy individuals based on Holter recording technology

(2007) Martino Vaglio et al.   HEART RHYTHM

Commentary on the Clinical Relevance of Concentration/QTc Relationships for New Drug Candidates

(2007) Daniel Bloomfield 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