Science Abstracts
The use of electrocardiograms in clinical trials: a public discussion of the proposed ICH E14 regulatory guidance
July 2005
July 2005
Authors : Icilio Cavero , William Crumb2
Affliation :
1Via dei Bacchettoni 19B, 55100 Lucca, Italy. iciliocavero@aol.com
2Zenas Technologies L.L.C., 5896 Fleur de Lis Drive, New Orleans, LA 70124, USA. zenasllc@bellsouth.net
DOI : 10.1517/14740338.4.4.795
Published in : Expert Opin. Drug Saf. Volume 4 Issue 4 2005 pages 795 799
Subject: Meeting Highlights
Keywords: E14 , Food and Drug Administration (FDA) , International Conference on Harmonisation (ICH) guidelines , nonclinical evaluation , repolarisation risk , S7B , thorough QT/QTc study
Abstract
This meeting, jointly sponsored by the FDA, Drug...
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