Keyword Analysis & Research: tqt
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Finding a Better Test for Predicting the Risk Drugs Pose to the Heart
https://www.fda.gov/drugs/regulatory-science-action/impact-story-finding-better-test-predicting-risk-drugs-pose-heart
WEBFDA research has laid the groundwork for replacing the thorough QT (TQT) study, a costly clinical trial required to determine whether new drugs cause abnormal …
DA: 60 PA: 29 MOZ Rank: 93
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Evaluating cardiac risk: exposure response analysis in early clinical
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5912368/
WEBApr 18, 2018 · Drug developers now have a choice in how proarrhythmia risk can be evaluated; the options include a dedicated thorough QT (TQT) study or …
DA: 26 PA: 14 MOZ Rank: 76
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QT assessments in oncology drug development and related labels.
https://ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.e14127
WEBMay 25, 2020 · Background: A thorough QT (TQT) study, designed to evaluate whether a new drug excludes a small mean increase in the QTc interval (i.e., …
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The thorough QT/QTc study 4 years after the implementation of the IC…
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2823351/
WEBAbstract. The ICH E14 guidance on how to clinically assess a new drug's liability to prolong the QT interval was adopted in May 2005. A centre-piece of the …
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E14 Clinical Evaluation of QT/QTc Interval Prolongation and
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e14-clinical-evaluation-qtqtc-interval-prolongation-and-proarrhythmic-potential-non-antiarrhythmic
WEBThe TQT study results in a positive finding as defined by the E14 criteria* at the therapeutic dose, with a mean prolongation Intensive ECG monitoring …
DA: 90 PA: 9 MOZ Rank: 83