| Document Type
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BL
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| Record Number
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1008272
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| Doc. No
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b762642
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| Title & Author
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Cardiac safety of noncardiac drugs : : practical guidelines for clinical research and drug development /\ edited by Joel Morganroth, Ihor Gussak.
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| Publication Statement
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Totowa, N.J. :: Humana Press,, ©2005.
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| Page. NO
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1 online resource (xii, 361 pages) :: illustrations
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| ISBN
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1280359366
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: 158829515X
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: 1592598846
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: 9781280359361
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: 9781588295156
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: 9781592598847
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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Cardiac Safety of Noncardiac Drugs -- Preclinical and Pharmacogenomic Cardiac Safety Evaluations -- Molecular Physiology of Ion Channels That Control Cardiac Repolarization -- Cellular, Molecular, and Pharmacologic Mechanisms Underlying Drug-Induced Cardiac Arrhythmogenesis -- hERG Assay, QT Liability, and Sudden Cardiac Death -- Pharmacogenomics in Drug Development -- Clinical Methodologies and Technical Aspects of Assessing Cardiac Safety of Investigational Drugs: Focus on Cardiac Repolarization -- Assessment of Ventricular Repolarization From Body-Surface ECGs in Humans -- ECG Acquisition and Signal Processing -- Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation -- Holter Monitoring for QT -- Application of ELectrocardiology in Clinical Research -- Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment -- Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugs -- Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials -- Cardiac Arrhythmia Assessment in Phase IV Clinical Studies -- Statistical Analysis Plans for ECG Data -- Interpretation of Clinical ECG Data -- Regulatory COnsiderations -- The FDA's Digital ECG Initiative and Its Impact on Clinical Trials -- Quality Control and Quality Assurance for Core ECG Laboratories -- ECG Digital Communities and Electronic Reporting of Cardiac Safety Data.
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| Abstract
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"Authoritative and up-to-date, Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development offers clinical researchers in industry and academia expert practical advice on establishing their product's cardiac safety, predicting regulatory actions, and getting it successfully to market."--Jacket.
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| Subject
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Cardiovascular toxicology.
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Drugs-- Side effects-- Testing.
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Electrocardiography.
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Heart-- Effect of drugs on.
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Cœur, Effets des médicaments sur le.
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Électrocardiographie.
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Médicaments-- Effets secondaires-- Essais.
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Toxicologie cardiovasculaire.
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Biomédecine.
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Cardiovascular toxicology.
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Electrocardiography.
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Heart-- Effect of drugs on.
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MEDICAL-- Cardiology.
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Sciences de la vie.
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Arrhythmia-- chemically induced.
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Cardiovascular toxicology.
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Clinical trials.
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Drug Approval.
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Drugs-- Side effects-- Testing.
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Electrocardiography-- drug effects.
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Electrocardiography.
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Heart-- drug effects.
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Heart-- Effect of drugs on.
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Pharmaceutical Preparations-- adverse effects.
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Arrhythmias, Cardiac-- chemically induced.
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Heart-- drug effects.
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Clinical Trials
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Drug Approval.
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Drug-Related Side Effects and Adverse Reactions.
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Electrocardiography-- drug effects.
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| Dewey Classification
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616.1/07
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| LC Classification
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RC677.C36 2005
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| NLM classification
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2005 A-635
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WG 330C2699 2005
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44.85bcl
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R540. 2clc
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| Added Entry
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Gussak, Ihor.
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Morganroth, Joel.
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