Key result
Emerging trends in cardiac safety highlight the importance of preclinical hERG and telemetric studies, as well as clinical thorough QT studies, to establish safety margins for proarrhythmic risk.
Design
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Reinforces QT assessment protocols in drug development; leaves open validation of safety margins against clinical arrhythmic outcomes.
This meeting report summarizes emerging regulatory and preclinical/clinical strategies for assessing drug-induced proarrhythmic risk, emphasizing QT interval evaluation.
Hanton et al. (2006) conducted a review in Proarrhythmic risk. Emerging trends in cardiac safety highlight the importance of preclinical hERG and telemetric studies, as well as clinical thorough QT studies, to establish safety margins for proarrhythmic risk.
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