Abstract
Ten years after the adoption of the E14 guideline of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) on “The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs” the discussion of new methods for the clinical assessment of this potential has intensified in two arenas: more powerful methods of statistical analysis allow to reliably exclude a prolongation of the QT interval corrected for heart rate (QTc) of regulatory concern based on data from Phase I single or multiple ascending dose (SAD/MAD) studies and more specific biomarkers than the QTc interval itself have been established.
Published Version
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