The mission of the HESI Cardiac Safety Committee is to improve public health by reducing unanticipated cardiovascular-related adverse effects from drugs or chemicals, and to develop innovative approaches to support early detection and prediction as well as improved understanding of cardiovascular toxicology and pathobiology.
National Institute of Environmental Health Sciences, National Toxicology Program
US Food and Drug Administration
This workshop was co-sponsored by co-sponsored by the HESI Cardiac Safety Technical Committee and the Safety Pharmacology Society.
This event was sponsored by the HESI Technical Committee on Cardiac Safety.
This event was sponsored by the HESI Cardiac Safety Committee.
The HESI Cardiac Safety Technical Committee presented gave two presentations (“A HESI Consortium Approach to Assess the Human Predictive Value of Non-Clinical Repolarization Assays") at this event.
This workshop was sponsored by the HESI Biomarkers of Toxicity Committee.
The strengths and limitations of three nonclinical repolarization assays used to define the risk of clinical drug-induced delayed ventricular repolarization (a surrogate marker of the rare but potentially lethal arrhythmia Torsades de Pointes) were compared during a retrospective analysis of an anonymized database of 150 ...
Heart rate correction methods are frequently used when analyzing data collected during the drug development process to better understand the QT interval. There is variability in this methodology and the optimal heart rate correction formula is often debated. This paper details a study that explored the ...
This article characterizes a time course model of inflammation and hemostatic activation in rats treated with bacterial endotoxin (lipopolysaccharide, LPS) through a combination of traditional histologic and clinicopathologic endpoints and analyses of novel circulating biomarkers, including microRNA (miRNA) and ...
The importance of drug-induced effects on the inotropic state of the heart is well known. Unlike hemodynamic and cardiac electrophysiological methods, which have been routinely used in drug safety testing for years, the non-clinical assessment of drug effects on myocardial contractility is used less frequently with ...
Advances in cancer therapy has resulted in more cancer survivors, and now quality of life throughout treatment and surviving years is becoming a new focus for the scientific community. There are often unintended toxicities related to cancer therapies. HESI established the THRIVE program to address quality-of-life research.
The implementation of the ICH S7B and E14 guidelines has been successful in preventing the introduction of potentially torsadogenic drugs to the market, but it has also unduly constrained drug development by focusing on hERG block and QT prolongation as essential determinants of proarrhythmia risk.