The prospective IQ-CSRC trial: A prototype early clinical proarrhythmia assessment investigation for replacing the ICH E14 thorough QTc (TQT) study

Cavero Icilio; Holzgrefe Henry; Clements Mike

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The prospective IQ-CSRC trial: A prototype early clinical proarrhythmia assessment investigation for replacing the ICH E14 thorough QTc (TQT) study

机译：预期IQ-CSRC试验：替代ICH E14彻底QTC（TQT）研究的原型早期临床预审性评估调查

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Introduction: Early clinical Phase I ECG investigations designed to replace the currently applied thorough QT (TQT) study are reviewed to examine how they could complement and verify the conclusions of nonclinical investigations and, in particular, the Comprehensive in vitro Proarrhythmia Assay (CiPA).

机译：简介：审查了旨在取代目前应用的ECG调查的ECG调查，审查了他们如何补充和验证非临床调查的结论，特别是全面的体外预血淋淋的测定（CIPA）。

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来源
《Journal of Pharmacological and Toxicological Methods》 |2016年第null期|共8页
作者
Cavero Icilio; Holzgrefe Henry; Clements Mike;
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作者单位

54 Rue Glaciere F-75013 Paris France;

13765 Seabiscuit Dr Reno NV USA;

GE Healthcare Life Sci Maynard Ctr Cardiff CF14 7YT S Glam Wales;

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原文格式 PDF
正文语种 eng
中图分类药理学;
关键词
Exposure-response relationship analysis; Positive and negative QTc-prolongers; ECG restitution; Intensive early phase I ECG study; IQ-CSRC prospective study; Proarrhythmic metrics; Thorough QT study (TQT);

机译：曝光响应关系分析;正负QTC-遍布;心电图归还;密集早期ICG研究;IQ-CSRC预期研究;预训练度量;彻底的QT学习（TQT）;

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1. The prospective IQ-CSRC trial: A prototype early clinical proarrhythmia assessment investigation for replacing the ICH E14 thorough QTc (TQT) study [J] . Cavero Icilio, Holzgrefe Henry, Clements Mike Journal of Pharmacological and Toxicological Methods . 2016,第Null期

机译：IQ-CSRC前瞻性试验：替代ICH E14全面QTc（TQT）研究的早期临床心律失常评估调查原型
2. The IQ-CSRC prospective clinical phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?" [J] . DarpoB., SarapaN., GarnettC., Annals of noninvasive electrocardiology: the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc . 2014,第1期

机译：IQ-CSRC前瞻性临床1期研究：“使用暴露反应分析进行早期QT评估可以代替彻底的QT研究吗？”
3. Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14 [J] . Darpo Borje, Garnett Christine, Keirns James, Drug safety: An international journal of medical toxicology and drug experience . 2015,第9期

机译：IQ-CSRC前瞻性研究的意义：修订ICH E14的时机
4. A Prospective Randomized Clinical Trial for Measuring Radiology Study Reporting Time on Artificial Intelligence-Based Detection of Intracranial Hemorrhage in Emergent Care Head CT [C] . Axel Wismüller, Larry Stockmaster Conference on Medical Imaging : Biomedical Applications in Molecular, Structural, and Functional Imaging . 2020

机译：一种预期随机临床试验，用于测量放射学研究报告时间对突出护理头CT中颅内出血的基于人工智能检测
5. Applying survival analysis techniques to interim analysis and sample size reassessment of clinical trials with a dichotomous endpoint. [D] . Pedley, Alison L. 2011

机译：将生存分析技术应用于具有二分终点的临床试验的中期分析和样本量重新评估。
6. Assessment of QTc-prolonging potential of BX471 in healthy volunteers. A ‘thorough QTc study’ following ICH E14 using various QT correction methods [O] . Marc Vandemeulebroecke, Jürgen Lembcke, Herbert Wiesinger, 2009

机译：在健康志愿者中评估BX471延长QTc的潜力。 ICH E14之后使用各种QT校正方法进行的全面QTc研究
7. Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates) [O] . David G. Strauss, Wendy W. Wu, Zhihua Li, 2021

机译：翻译模型和工具减少临床试验，提高QTC和预审风险的监管决策（ICH E14 / S7B更新）

The prospective IQ-CSRC trial: A prototype early clinical proarrhythmia assessment investigation for replacing the ICH E14 thorough QTc (TQT) study

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