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Cardiac electrophysiology / Circulatory system / Piperazines / QT interval / Channelopathy / Syndromes / Long QT syndrome / HERG / Torsades de pointes / Cardiac dysrhythmia / Chemistry / Physiology


Guidance for Industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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Document Date: 2006-11-13 08:05:27

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File Size: 66,91 KB

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City

Rockville / /

Company

Expert Working Group / /

Country

Japan / United States / /

Facility

QRS complex / Rockville Pike / /

IndustryTerm

pharmaceutical agent / clinical trial protocol / food ingestion / /

MedicalCondition

arrhythmia / sudden cardiac death / cardiac arrhythmias / polymorphic ventricular tachyarrhythmia / torsade de pointes / ventricular tachyarrhythmias / heart failure / ventricular fibrillation / hypokalemia / Long QT Syndrome / /

Organization

U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / Training and Communication Division of Drug Information / Food and Drug Administration / office of Training / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / European Union / ICH Steering Committee / Center for Biologics Evaluation and Research / HFD-240 Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / office of Communication / Training and Manufacturers Assistance / /

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ProvinceOrState

Maryland / /

Technology

pharmacokinetics / clinical trial protocol / drug development / /

URL

http /

SocialTag