The ICH guideline E14 on QT Preloader

The ICH guideline E14 on QT - PowerPoint PPT Presentation


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Overview. Issue and historyWhy is QT prolongation of interest, history of the guidanceHigh level outline of the current versionTopics of specific interest and comments from EFSPI statisticians. QT prolongation: the issue. Torsade de Pointes is a potentially fatal arrhythmia,i. e. a severe disturbance of normal heart rhythm.It can be induced by some drugs in patients when other risks are present at the same time.QT interval prolongation is a biomarker for torsade de poi1139

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