Key result
The Thorough QT Study, mandated since 2005 to evaluate drug-induced QTc prolongation, is a resource-intensive process whose future utility is being questioned.
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Design
Editorial
Discusses the history, impact, and potential future of the dedicated Thorough QT study mandated by ICH E-14 guidance for new drugs.
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Sager et al. (2014) reported an editorial. The Thorough QT Study, mandated since 2005 to evaluate drug-induced QTc prolongation, is a resource-intensive process whose future utility is being questioned.
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