Abstract
Cardiac safety of noncardiac drugs has become a major concern in recent years. Episodes of Torsade de Pointes (TdP) have been linked to QT prolongation from drugs such as the antihistamine terfenadine (1). Regulators have responded by routinely requesting QT prolongation studies in human subjects to determine a drug’s effects on cardiac safety. The recent QT concept paper put forth by the US Food and Drug Administration (FDA) and Health Canada November 2002 discusses definitive QT studies with a positive control and being able to detect a change in QT on the order of 5 ms (2).
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References
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© 2005 Humana Press Inc., Totowa, NJ
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Brown, B.D. (2005). The FDA’s Digital ECG Initiative and Its Impact on Clinical Trials. In: Morganroth, J., Gussak, I. (eds) Cardiac Safety of Noncardiac Drugs. Humana Press. https://doi.org/10.1007/978-1-59259-884-7_16
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DOI: https://doi.org/10.1007/978-1-59259-884-7_16
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