Electrocardiographic biomarkers to confirm drug's electrophysiological effects used for proarrhythmic risk prediction under CiPA

Author:

Vicente JoseORCID,Hosseini Meisam,Johannesen Lars,Strauss David G.

Funder

U.S. Food and Drug Administration's Critical Path Initiative

U.S. Food and Drug Administration's Office of Women's Health

Publisher

Elsevier BV

Subject

Cardiology and Cardiovascular Medicine

Reference23 articles.

1. Guideline for Industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs;International Council on Harmonisation,2005

2. Dealing with global safety issues: was the response to QT-liability of non-cardiac drugs well coordinated?;Stockbridge;Drug Saf,2013

3. Drug-induced prolongation of the QT interval;Roden;N Engl J Med,2004

4. Early afterdepolarizations: mechanism of induction and block. A role for L-type Ca2+ current;January;Circ Res,1989

5. ICH Topic S7B the Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals;International Council on Harmonisation,2005

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