Key result
Thorough QT/QTc studies require inter- and intra-reader variability analysis to ensure quality in detecting a mean drug-induced QTc prolongation of >5 ms.
Design
Other
Authors
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Variability analysis is now required for TQT study quality; extends E14 guideline application with ANOVA-based ECG reader assessment.
Provides a methodological framework using ANOVA to assess ECG reader variability in thorough QT/QTc studies as required by E14 guidelines.
Natekar et al. (2008) conducted a review in QT/QTc prolongation. Inter- and intra-reader variability analysis was evaluated. Thorough QT/QTc studies require inter- and intra-reader variability analysis to ensure quality in detecting a mean drug-induced QTc prolongation of >5 ms.
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