Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5841014 | Journal of Pharmacological and Toxicological Methods | 2013 | 6 Pages |
Abstract
Introduction: The evaluation of cardiovascular side-effects is a critical element in the development of all new drugs and chemicals. Cardiac safety issues are a major cause of attrition and withdrawal due to adverse drug reactions (ADRs) in pharmaceutical drug development. Methods: The evolution of the HESI Technical Committee on Cardiac Safety from 2000-2013 is presented as an example of an effective international consortium of academic, government, and industry scientists working to improve cardiac safety. Results and Discussion: The HESI Technical Committee Working Groups facilitated the development of a variety of platforms for resource sharing and communication among experts that led to innovative strategies for improved drug safety. The positive impacts arising from these Working Groups are described in this article.
Keywords
CDERcTnIKrTorsades de pointesADRsThorough QT studyQTcTDPILSIEWGHERGTQTNDAFDAEMAPSTCUS FDACardiac repolarizationEuropean Medicines agencyUnited States Food and Drug AdministrationIntegrated risk assessmentelectrocardiogramECGindCardiac safetyNew drug applicationcardiac biomarkersCardiac troponinDelayed rectifier potassium currentInvestigational New DrugStem cellscorrected QT intervalcardiovascularAnimal modelsCenter for Drug Evaluation and ResearchICHInternational Life Sciences InstituteHealth and Environmental Sciences InstituteHESIAdverse drug reactionshuman Ether-a-go-go Related GeneInternational Conference on Harmonization
Related Topics
Health Sciences
Pharmacology, Toxicology and Pharmaceutical Science
Pharmacology
Authors
Jennifer B. Pierson, Brian R. Berridge, Marjory B. Brooks, Kevin Dreher, John Koerner, A. Eric Schultze, R. Dustan Sarazan, Jean-Pierre Valentin, Hugo M. Vargas, Syril D. Pettit,