4.3 Article Proceedings Paper

Drug-induced prolongation of the OT interval: regulatory dilemmas and implications for approval and labelling of a new chemical entity

Journal

FUNDAMENTAL & CLINICAL PHARMACOLOGY
Volume 16, Issue 2, Pages 147-156

Publisher

BLACKWELL PUBLISHING LTD
DOI: 10.1046/j.1472-8206.2002.00083.x

Keywords

labelling; new chemical entities; QT interval; regulatory approval; risk/benefit; torsade de pointes

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The views expressed in this paper are those of the author and do not necessarily represent the views or the opinions of Medicines Control Agency, other regulatory authorities or any of their advisory committees.

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