2004D-0378 International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
FDA Comment Number : EC4
Submitter : Mrs. kim salzwedel Date & Time: 11/17/2005 02:11:28
Organization : Mrs. kim salzwedel
Category : Drug Industry
Issue Areas/Comments
GENERAL
GENERAL
please demand guidance intended to
facilitate the nonclinical assessment of the effects of pharmaceuticals
on ventricular repolarization and proarrhythmic risk is implemented.