Publications

January 2018 - Review of the "CiPA" initiative and design of a prospective clinical validation study. The Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative is developing and validating a mechanistic-based assessment of the proarrhythmic risk of drugs. CiPA proposes...

 

April 2017 - Is associated with drug-induced QT prolongation and torsade de pointes risk. Drug-induced QT interval prolongation, a risk factor for life-threatening ventricular arrhythmias, is a potential side effect...

 

Dec 2016 - Drugs that prolong the heart rate corrected QT interval (QTc) on the electrocardiogram (ECG) by blocking the hERG potassium channel and also block inward currents (late sodium or L-type calcium) are not associated with...

 

Dec 2016 - Assessment of drug-induced Proarrhythmia risk. Prolongation of the heart rate corrected QT (QTc) interval is a sensitive marker of torsade de pointes risk; however it is not specific as...

 

June 2016 - This publication is designed to evaluate the relative bioavailability of effervescent NAC tablets versus oral solution NAC through an open-label, randomized, single-dose, crossover, relative bioavailability study.  

 

February 2016 - Results from a prospective clinical trial. Drug-induced long QT syndrome has resulted in many drugs being withdrawn from the market...

 

December 2015 - This publication provides a brief introduction to the FDA's ICH E14 guidance, its limitations, and provides key metrics that drug developers should consider when conducting a TQT Study.

 

April 2015 - This publication tests the overall response relationship between hERG potassium channel block and T wave morphology changes.

 

November 2014 - The randomized study of Dofetilide, Quinidine, Ranolazine, and Verapamil.  

 

September 2014 - This publication is based on a thorough QT study of administering Oritavancin, a lipoglycopeptide antibiotic that is being developed to fight bacterial activity again Gram-positive infections .

March 2014 - This publication is a Phase I, randomized, placebo-controlled, four-period crossover study to examine the effect(s) of APF530, granisetron, and moxifloxacin on the QTc interval of healthy male and female subjects.

 

Nov 2013 - This publication evaluates Canakinumab antibodies and the bioequivalence of pre-filled syringe and reconstructed formulations administered in healthy subjects.

 

This slide publication results from the importance of multi-channel block, analysis of 34 Thorough QT studies, two FDA-sponsored clinical trials, and cardiomyocyte experiments.

 

This publication is a clinical study to assess repolarization effects of granisetron administered intravenously and by a granisetron transdermal system.