E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)
- Series Title(s):
- Guidance for industry
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.
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2017
- Arrhythmias, Cardiac -- chemically induced Arrhythmias, Cardiac -- diagnosis Cardiac Electrophysiology -- methods Cardiac Electrophysiology -- standards Drug Approval Electrocardiography -- standards Long QT Syndrome -- chemically induced Cardiotoxins Clinical Trials as Topic Congresses as Topic Diagnosis, Computer-Assisted Drug-Related Side Effects and Adverse Reactions International Cooperation Pharmaceutical Preparations -- administration & dosage Reference Standards Research Design Sex Factors Humans Europe Japan United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Guideline Technical Report
- The National Library of Medicine believes this item to be in the public domain. (More information)
- 1 online resource (1 PDF file (18 pages)).
- Revision 2
- NLM Unique ID:
- 101712951 (See catalog record)