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Detection of QTc Effects in Small Studies—Implications for Replacing the Thorough QT Study

BACKGROUND: ECG assessment with exposure response analysis applied to data from First‐in‐Man studies has been proposed to replace the thorough QT study for the detection of small QT effects. METHODS: Data from five thorough QT studies, three with moxifloxacin, one study with a drug with a large QTc...

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Detalhes bibliográficos
Publicado no:Ann Noninvasive Electrocardiol
Main Authors: Ferber, Georg, Zhou, Meijian, Darpo, Borje
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley and Sons Inc. 2014
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6931744/
https://ncbi.nlm.nih.gov/pubmed/25367715
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/anec.12227
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