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REGULATORY UPDATES: ICH E14 draft consensus guideline on clinical evaluation of QT/QTc interval prolongation
Author(s) -
Patterson Scott D.
Publication year - 2004
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.142
Subject(s) - qt interval , guideline , prolongation , medicine , intensive care medicine , cardiology , pathology
Abstract ICH E14 calls for public comment by epidemiologists and statisticians on the practical implications of thresholds to be used for regulatory decision‐making. Readers involved in QT/QTc assessment in drug development and those with an interest in this area are encouraged to give the topic some thought and to be prepared to engage in public debate on the proposed ICH E14 guidance in late 2004 and early 2005. Copyright © 2004 John Wiley & Sons Ltd.