2023
DOI: 10.1111/cts.13491
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Concentration QTc analysis of giredestrant: Overcoming QT/heart rate confounding in the presence of drug‐induced heart rate changes

Abstract: Concentration-QTc (C-QTc) analysis has become a common approach for evaluating proarrhythmic risk and delayed cardiac repolarization of oncology drug candidates. Significant heart rate (HR) change has been associated with certain classes of oncology drugs and can result in over-or underestimation of the true QT prolongation risk. Because oncology early clinical trials typically lack a placebo control arm or time-matched, treatment-free baseline electrocardiogram collection, significant HR change brings additio… Show more

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