Publications

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.  

 

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.

 

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 .

July 2014 - This publication investigates a randomized controlled clinical trial supporting the hypothesis of differentiating drug-induced multi-channel block on the electrocardiogram.  

 

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.