Mechanistic Model-Informed Proarrhythmic Risk Assessment of Drugs: Review of the “CiPA” Initiative and Design of a Prospective Clinical Validation Study-Reference-Cited by-同舟云学术

Mechanistic Model-Informed Proarrhythmic Risk Assessment of Drugs: Review of the “CiPA” Initiative and Design of a Prospective Clinical Validation Study

Published:2017-11-16 Issue:1 Volume:103 Page:54-66
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Vicente Jose¹,Zusterzeel Robbert²,Johannesen Lars²,Mason Jay³⁴,Sager Philip⁵,Patel Vikram²,Matta Murali K.²,Li Zhihua²,Liu Jiang²,Garnett Christine¹,Stockbridge Norman¹,Zineh Issam²,Strauss David G.²

Affiliation:

1. Office of New Drugs, Center for Drug Evaluation and Research; United States Food and Drug Administration; Silver Spring Maryland USA

2. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research; United States Food and Drug Administration; Silver Spring Maryland USA

3. Department of Medicine, Division of Cardiology; University of Utah; Salt Lake City Utah USA

4. Spaulding Clinical Research; West Bend Wisconsin USA

5. Stanford University; Palo Alto California USA

Funder

FDA Safety Research Interest Group

Critical Path Initiative in the Center for Drug Evaluation and Research

FDA's Office of Women's Health

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference60 articles.

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2. International Council on Harmonisation ICH Topic S7B the Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals . http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S7B/Step4/S7B_Guideline.pdf 2005

3. International Council on Harmonisation Guideline for Industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs . https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf 2005

4. International Council on Harmonisation ICH E14 Guideline: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions & Answers (R3) . http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Q_As_R3__Step4.pdf 2015

5. A quantitative framework to evaluate proarrhythmic risk in a first-in-human study to support waiver of a thorough QT study;Nelson;Clin. Phamacol. Ther.,2015

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