Pre-Clinical QT Prolongation Guidance Urges In Vitro, In Vivo Studies
This article was originally published in The Pink Sheet Daily
Executive SummaryFDA's 1draft guidance on preclinical evaluation of QT prolongation urges drug companies to initiate follow-up studies when nonclinical studies are inconsistent
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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.