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Health / Cardiac electrophysiology / Pharmacology / Ion channels / Syndromes / HERG / QT interval / Long QT syndrome / Torsades de pointes / Biology / Cardiac dysrhythmia / Medicine


Guidance for Industry S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
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Document Date: 2005-10-17 17:55:35


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File Size: 51,75 KB

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City

Rockville / /

Company

Expert Working Group / Human Pharmaceuticals / /

Country

Japan / United States / /

Event

FDA Phase / /

Facility

QRS complex / Rockville Pike / /

IndustryTerm

test systems / chemical/pharmacological class / pharmaceuticals / gene products / appropriate test systems / marketed pharmaceuticals / chemical entities / physiological systems / pharmaceutical-induced prolongation / heterologous expression systems / /

MedicalCondition

convulsion / tremor / torsade de pointes / hypokalemia / structural heart disease / bradycardia / sustained downward stroke / ventricular tachyarrhythmia / /

Organization

Repeated administration / 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 / HFD-240 Center for Drug Evaluation / 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 / Center for Biologics Evaluation and Research Food and Drug Administration / office of Communication / Training and Manufacturers Assistance / /

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Position

Investigator / C. General / General / /

Product

M-16 / Ca2 / /

ProvinceOrState

Maryland / /

Technology

drug development / /

URL

http /

SocialTag