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Assessment of QTc Prolongation for Non‐Cardiac‐Related Drugs from a Drug Development Perspective
Author(s) -
Bonate Peter L.,
Russell Tanya
Publication year - 1999
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00912709922007912
Subject(s) - drug , medicine , qt interval , prolongation , repolarization , intensive care medicine , long qt syndrome , drug development , cardiac arrhythmia , perspective (graphical) , ventricular repolarization , pharmacology , cardiology , computer science , atrial fibrillation , artificial intelligence , electrophysiology
It is increasingly likely that non‐cardiac‐related drugs will need to be routinely analyzed for their ability to prolong cardiac repolarization. This leads to potential problems for drug companies in general and statisticians in particular. A number of issues immediately arise in regard to answering the question, “Does drug X prolong cardiac repolarization?” These include identifying what is the desired outcome, what is the dependent variable, and what analysis method should be used. The purpose of this article is bring to to light some of the issues regarding the analysis of QTc data, the advantages and disadvantages of these analysis methods, and some general recommendations.