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BackgroundECG assessment with exposure response analysis applied to data from First‐in‐Man studies has been proposed to replace the thorough QT study for the detection of small QT effects.
MethodsData from five thorough QT studies, three with moxifloxacin, one study with a drug with a large QTc effect (∼25 ms) and one with ketoconazole with a smaller QT effect (∼8 ms) were used. By subsampling, studies...
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