QT as a safety biomarker in drug development.

Authors

• D J Whellan
• C L Green
• J P Piccini
• M W Krucoff

Publication/Presentation Date

7-1-2009

Abstract

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.

Volume

86

Issue

1

First Page

101

Last Page

104

ISSN

1532-6535

Published In/Presented At

Whellan, D. J., Green, C. L., Piccini, J. P., & Krucoff, M. W. (2009). QT as a safety biomarker in drug development. Clinical pharmacology and therapeutics, 86(1), 101–104. https://doi.org/10.1038/clpt.2009.70

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

19474784

Department(s)

Administration and Leadership

Document Type

Article