Modeling and Interpreting QTc Prolongation in Clinical Pharmacology Studies

The International Conference on Harmonisation E14 (2004) calls for public comment by statisticians on the practical implications of the proposed guidance to monitor for QTc prolongation. Of particular interest is consideration of the statistical properties of various end points proposed for measurem...

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Bibliographic Details
Published in:Drug information journal 2005-10, Vol.39 (4), p.437-445
Main Authors: Patterson, Scott D., Jones, Byron, Zariffa, Névine
Format: Article
Language:English
Subjects:
International conferences
Pharmaceutics
Pharmacology
Prolongation
Statistical inference
Statistical methods
Statistics
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Summary:The International Conference on Harmonisation E14 (2004) calls for public comment by statisticians on the practical implications of the proposed guidance to monitor for QTc prolongation. Of particular interest is consideration of the statistical properties of various end points proposed for measurement. Methods of analysis and statistical inference are developed for the QTc end points considered.
ISSN:2168-4790
0092-8615
2168-4804
2164-9200
DOI:10.1177/009286150503900410