Sample size determination for cardiodynamic ECG assessment using the Concentration-QTc analysis method
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Concentration-QTc (C-QTc) analysis was accepted to serve as an alternative to the by-time point analysis with intersection-union test (IUT) as the primary basis for decisions to classify the arrhythmogenic risk of a drug by ICH E14 Q&As (R3) in December 2015. ... ...
