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Correction for QT/RR Hysteresis in the Assessment of Drug‐Induced QTc Changes—Cardiac Safety of Gadobutrol

Background: The so‐called thorough QT/QTc (TQT) studies required for every new pharmaceutical compound are negative if upper single‐sided 95% confidence interval (CI) of placebo and baseline corrected QTc prolongation is <10 ms. This tight requirement has many methodological implications. If the...

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Vydáno v:Ann Noninvasive Electrocardiol
Hlavní autoři: Malik, Marek, Hnatkova, Katerina, Schmidt, Anna, Smetana, Peter
Médium: Artigo
Jazyk:Inglês
Vydáno: Blackwell Publishing Inc 2009
Témata:
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC6932186/
https://ncbi.nlm.nih.gov/pubmed/19614635
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/j.1542-474X.2009.00304.x
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