Practice and challenges of thorough QT studies

被引：18
|
作者：
Stockbridge, Norman [3 ]
Zhang, Joanne [4 ]
Garnett, Christine [5 ]
Malik, Marek [1 ,2 ]
机构：
[1] St Pauls Cardiac Electrophysiol, London, England
[2] Univ London, London, England
[3] US FDA, Div Cardiovasc & Renal Prod, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[4] US FDA, Div Biometr 6, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[5] US FDA, Div Pharmacometr, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA
来源：
JOURNAL OF ELECTROCARDIOLOGY | 2012年 / 45卷 / 06期
关键词：
QT interval; Torsade de pointes tachycardia; Drug safety; TORSADE-DE-POINTES; PHARMACODYNAMIC-ANALYSIS; PHARMACOKINETICS; PROLONGATION; MOXIFLOXACIN; DISOPYRAMIDE; QUINIDINE; INTERVAL; DESIGN; MODEL;
D O I：
10.1016/j.jelectrocard.2012.07.020
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
The drug-induced Torsade de Pointes (TdP) tachycardia is a known regulatory problem which led to the concept of the so-called thorough QT (TQT) studies now required for practically every new pharmaceutical compound. This review summarizes the concept of the TQT studies, their statistical evaluation, and related pharmacodynamic /pharmacokinetic modeling. The review also lists suggestions of how to make TQT studies more efficient and how to improve the interpretation of clinical data obtained during drug development to identify drugs prone to TdP induction more effectively. (C) 2012 Elsevier Inc. All rights reserved.
引用
收藏
页码：582 / 587
页数：6
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