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Evaluating whether a new medication prolongs  QT  intervals is a critical safety activity that is conducted in a sensitive animal model during non‐clinical drug development. The importance of  QT  liability detection has been reinforced by non‐clinical [International Conference on Harmonization ( ICH )  S 7 B ] and clinical ( ICH E 14) regulatory guidance from the  I nternational  C onference on  H armonization. A key challenge for the cardiovascular safety community is to understand how the finding from a non‐clinical  in vivo   QT  assay in animals predicts the outcomes of a clinical  QT  evaluation in humans. The  H ealth and Environmental  S ciences  I nstitute  P ro‐ A rrhythmia  W orking  G roup performed a literature search (1960–2011) to identify both human and non‐rodent animal studies that assessed  QT  signal concordance between species and identified drugs that prolonged or did not prolong the  QT  interval. The main finding was the excellent agreement between  QT  results in humans and non‐rodent animals. Ninety‐one percent (21 of 23) of drugs that prolonged the  QT  interval in humans also did so in animals, and 88% (15 of 17) of drugs that did not prolong the  QT  interval in humans had no effect on animals. This suggests that  QT  interval data derived from relevant non‐rodent models has a 90% chance of predicting  QT  findings in humans. Disagreement can occur, but in the limited cases of  QT  discordance we identified, there appeared to be plausible explanations for the underlying disconnect between the human and non‐rodent animal  QT  outcomes.

Evaluation of drug‐induced QT interval prolongation in animal and human studies: a literature review of concordance