QT Prolongation Trial For All Drugs Recommended By ICH Draft Guidance
All drugs should undergo a single cardiac QT interval prolongation trial early in development, an International Conference on Harmonization draft guidance on clinical evaluation of QT prolongation, released Sept. 13, states
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The agency is looking at preclinical measurement of a drug’s effect on multiple ion channels, in silico modeling and stem cell assays as a possible alternative to “thorough” QT tests to assess the therapy’s impact on heart rhythm.
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 may be looking to expand the scope of public discussion in the development of regulatory policy regarding emerging scientific issues