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Tuesday, July 22, 2008 4:11:58 PM
Ilo- QT impact- my research shows no impact 2-Jul-08 05:37 pm
So - I did lots of reading today at FDA website.
Per their QT Guideline doc - Ilo should not have any problems with QT prolongation.-
Per Guideline doc- QT < 20msec are inconclusive , but some of these compounds have been associated with proarrhythmic risk. Also, looking at a few other drugs with QT prolongation on FDA site- even for instances of QT>500msec.... if the occurrence of >500msec is less than 1% - Drugs still approved with QT labelling. Ilo NDA had 3000 patients... so the 2 patients identified in early studies with >500msec are fairly irrelevant as pertains to approval.... (IMO).
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