QT Guidance Reducing Number Of Drugs Leaving Early Development, Firms Say
Stricter guidelines on QT prolongation are forcing manufacturers to drop compounds earlier in the development process, participants said during an FDA/Duke Cardiac Safety and Critical Path Initiative Think Tank meeting Oct. 11
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Approach is modeled after the interdisciplinary review team established more than a decade ago to review data on QT interval effects, FDA says; at a recent Duke meeting on assessing off-target pressor effects, discussion focused on lessons learned in the QT space that could be applied to studying blood pressure effects.
A clinical study funded by the Critical Path Initiative is looking at the change in a number of electrocardiogram parameters in patients given drugs known to prolong the QT interval and with varying risks for the abnormal heart rhythm.
FDA's partnership with the Duke Clinical Research Institute to develop tools for identifying the potential cardiac effects of drugs and devices will examine gender differences as one of its first projects