Publications

May 2020 - To prevent the risk of induced arrhythmias in cardiac drug development, it is important for developers and biotech companies to adhere to ECG safety requirements in early stage research. This article is taken from International Clinical Trials May 2020, pages 56-60. © Samedan Ltd.

 

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 Drug-induced long QT syndrome has resulted in many drugs being withdrawn from the market...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.