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QT as a Safety Biomarker in Drug Development
Author(s) -
Whellan DJ,
Green CL,
Piccini JP,
Krucoff MW
Publication year - 2009
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2009.70
Subject(s) - drug , food and drug administration , drug development , medicine , intensive care medicine , pharmacology , sudden death , biomarker , risk analysis (engineering) , biology , biochemistry
The cardiovascular safety of new drugs is an overarching concern for all stakeholders: the pharmaceutical industry and the US Food and Drug Administration (FDA) prior to approval and doctors and patients during postrelease drug use. Of the many cardiac safety concerns that accompany development of new drugs—including those related to vasculature and valvular tissue, the potential for myopathies, and the possibility of other electrophysiologic perturbations—the most pressing concern is the potential for ventricular arrhythmias causing sudden death.