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Medicine / Cardiac dysrhythmia / HERG / Long QT syndrome / QT interval / Torsades de pointes / KvLQT1 / Ventricular tachycardia / Cardiac action potential / Biology / Cardiac electrophysiology / Physiology


ICH S7B Guideline Step 2 Revision The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
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Document Date: 2004-09-10 06:20:27

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File Size: 52,34 KB

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Company

Human Pharmaceuticals / /

Country

Guinea / /

Event

FDA Phase / /

Facility

QRS complex / /

IndustryTerm

chemical entities / test systems / expression systems / pharmaceutical-induced prolongation / aqueous physiological salt solutions / chemical/pharmacological class / appropriate in vivo test systems / pharmaceuticals / gene products / appropriate test systems / in vivo test systems / marketed pharmaceuticals / in vitro test systems / heterologous expression systems / stable test systems / /

MedicalCondition

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

MedicalTreatment

intravenous infusion / /

Organization

Repeated administration / Food and Drug Administration / /

Position

Investigator / General / Guideline General / /

Product

M-16 / Ca2 / APD30 / /

Technology

drug metabolism / /

SocialTag