Detection of QTc Effects in Small Studies-Implications for Replacing the Thorough QT Study-Reference-Cited by-同舟云学术

Detection of QTc Effects in Small Studies-Implications for Replacing the Thorough QT Study

Published:2014-11-04 Issue:4 Volume:20 Page:368-377
ISSN:1082-720X
Container-title:Annals of Noninvasive Electrocardiology
language:en
Short-container-title:Ann Noninvasive Electrocardiol

Author:

Ferber Georg¹,Zhou Meijian²,Darpo Borje²³

Affiliation:

1. Statistik Georg Ferber GmbH; Riehen Switzerland

2. iCardiac Technologies; Rochester NY

3. Karolinska Institute; Division of Cardiovascular Medicine; Department of Clinical Sciences; Danderyd's Hospital; Stockholm Sweden

Publisher

Wiley

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine,General Medicine

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/anec.12227/fullpdf

Reference26 articles.

1. ICH E14 Questions & Answers http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf 2014

2. ICH Harmonized Tripartite Guideline E14 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf

3. Design of the “Thorough QT Study;Darpo;Clin Pharmacol Ther,2008

4. The thorough QT/QTc study 4 years after the implementation of the ICH E14 guidance;Darpo;Br J Pharmacol,2010

5. The cost-effectiveness of drug regulation: The example of thorough QT/QTc studies;Bouvy;Clin Pharmacol Ther,2012

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