FDA's insights: implementing new strategies for evaluating drug-induced QTc prolongation
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The questions and answers (Q&A) document for ICH E14/S7B provides the following advancements for QTc assessment: concentration-QTc modeling (C-QTc) as the primary analysis, accepting alternative approaches (Q&A 5.1 and 6.1) to thorough QT (TQT) studies, and in... ...
