نتایج جستجو برای: harmonization
تعداد نتایج: 4253 فیلتر نتایج به سال:
Evaluating whether a new medication prolongs QT intervals is a critical safety activity that is conducted in a sensitive animal model during non-clinical drug development. The importance of QT liability detection has been reinforced by non-clinical [International Conference on Harmonization (ICH) S7B] and clinical (ICH E14) regulatory guidance from the International Conference on Harmonization....
Current testing for proarrhythmic potential of drugs relies on determining their effect on the QT interval of the ECG. Because QT prolongation is frequently associated with blockade of the human ether-à-go-go related gene (hERG) channel, the International Conference on Harmonization (ICH) S7B guideline recommends an hERG inhibition assay as the first proxy for identifying such potential risk. S...
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