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GUIDANCE DOCUMENT

S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals October 2005

Final
Docket Number:
FDA-2004-D-0366
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance describes a nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization. The guidance includes information concerning nonclinical assays and integrated risk assessments. The assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk is the subject of active investigation. When additional data (nonclinical and clinical) are accumulated in the future, they will be evaluated and this guidance might be revised.


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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2004-D-0366.