Evaluation of Deutetrabenazine's Potential to Delay Cardiac Repolarization Using Concentration‐QTc Analysis
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DOI: 10.1002/cpdd.1161
Abstract: Deutetrabenazine (Austedo) is indicated in adults for chorea associated with Huntington disease and tardive dyskinesia. Escalating deutetrabenazine doses were administered to healthy volunteers who were cytochrome P450 2D6 extensive/intermediate metabolizers (EMs) or poor metabolizers (PMs)… read more here.
Keywords: evaluation; qtc analysis; deutetrabenazine; using concentration ... See more keywords
ECG Evaluation as Part of the Clinical Pharmacology Strategy in the Development of New Drugs: A Review of Current Practices and Opportunities Based on Five Case Studies
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DOI: 10.1002/jcph.2095
Abstract: The International Conference on Harmonization (ICH) E14 document was revised in 2015 to allow concentration–corrected QT interval (C–QTc) analysis to be applied to data from early clinical pharmacology studies to exclude a small drug‐induced effect… read more here.
Keywords: pharmacology; clinical pharmacology; qtc analysis; case ... See more keywords
Concentration QTc analysis of giredestrant: Overcoming QT/heart rate confounding in the presence of drug‐induced heart rate changes
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DOI: 10.1111/cts.13491
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… read more here.
Keywords: qtc analysis; oncology; heart rate;