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- Title
Regulatory watch: Speedy validation sought for new cardiotoxicity testing strategy.
- Authors
Chi, Kelly Rae
- Abstract
The article offers information on the new cardiotoxicity testing presented by the U.S. Food and Drug Administration (FDA), Cardiac Safety Research Consortium (CSRC), and the Health and Environmental Sciences Institute (HESI). The proposal entails two non-clinical approaches, electrophysiological tests on stem-cell-derived cardiomyocytes and an in silico model. It notes that Amgen's scientific director Hugo Vargas is hesitant to the new tools because of the necessity to addressed the key gaps.
- Subjects
CARDIOVASCULAR system; ELECTROPHYSIOLOGY; CLINICAL trials; TEST validity; VARGAS, Hugo; HEART cells; UNITED States. Food &; Drug Administration
- Publication
Nature Reviews Drug Discovery, 2013, Vol 12, Issue 9, p655
- ISSN
1474-1776
- Publication type
Article
- DOI
10.1038/nrd4112