E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)

E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2017
Language(s):
English
Format:
Text
Subject(s):
Arrhythmias, Cardiac -- chemically induced
Arrhythmias, Cardiac -- diagnosis
Cardiac Electrophysiology -- methods
Cardiac Electrophysiology -- standards
Drug Approval
Electrocardiography -- standards
Long QT Syndrome -- chemically induced
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Guideline
Technical Report
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (18 pages)).
Edition:
Revision 2
NLM Unique ID:
101712951 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101712951