The assessment of potential for QT interval prolongation with new pharmaceuticals Impact on drug development

被引：21

作者：

Gralinski, MR ^{[1
]}

机构：

[1] Pharmacia Corp, Metab & Safety Evaluat, Safety Pharmacol Dept, Skokie, IL 60077 USA

来源：

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS | 2000年 / 43卷 / 02期

关键词：

QT interval; drug development; electrocardiogram;

D O I：

10.1016/S1056-8719(00)00100-3

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Few examinations of a single physiological variable can end the development of a putative new pharmaceutical. Prolongation of the electrocardiographic QT interval is one of these tests. Recognizing the removal of several approved and widely used medicines, worldwide regulatory authorities have raised a heightened awareness on the submission of data surrounding the ventricular repolarization process. This review will discuss the anatomy and physiology surrounding the generation of the electrocardiographic QT interval and the consequences of its alteration. In addition, relevant models of preclinical safety and general guidelines for clinical examination in this area are discussed along with the impact of incorporating these assays into the drug development process. (C) 2000 Elsevier Science Inc. All rights reserved.

引用

页码：91 / 99

页数：9

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