| | ICH; Guidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for ... |
 | | If supported by the QT/QTc interval data from the early clinical studies, later clinical trials could expand the eligibility criteria to include a broader spectrum of patients who are likely to receive the drug once approved. |
 | | The available postmarketing adverse event data should be examined for evidence of QT/QTc interval prolongation and TdP and for adverse events possibly related to QT/QTc interval prolongation, such as cardiac arrest, sudden cardiac death and ventricular arrhythmias (e.g., ventricular tachycardia and ventricular fibrillation). |
 | | This guidance was developed within the Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. |
| www.fda.gov /cber/gdlns/iche14qtc.htm (6088 words) |