Title Cardiac safety of noncardiac drugs : practical guidelines for clinical research and drug development / edited by Joel Morganroth, Ihor Gussak

Published Totowa, N.J. : Humana Press, ©2005

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Description 1 online resource (xii, 361 pages) : illustrations Contents 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 Summary "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 Bibliography Includes bibliographical references and index In Springer e-books Subject Cardiovascular toxicology. Heart -- Effect of drugs on. Drugs -- Side effects -- Testing Electrocardiography. Drugs -- Side effects. Arrhythmias, Cardiac -- chemically induced Heart -- drug effects Clinical Trials Drug Approval Electrocardiography -- drug effects Drug-Related Side Effects and Adverse Reactions Electrocardiography MEDICAL -- Cardiology. Heart -- Effect of drugs on. Drugs -- Side effects -- Testing. Electrocardiography. Arrhythmia -- chemically induced. Heart -- drug effects. Clinical trials. Drug Approval. Electrocardiography -- drug effects. Pharmaceutical Preparations -- adverse effects. Cardiovascular toxicology. Biomédecine. Sciences de la vie. Drugs -- Side effects Cardiovascular toxicology Electrocardiography Heart -- Effect of drugs on Form Electronic book Author Morganroth, Joel Gussak, Ihor LC no. 2004014055 ISBN 158829515X 9781588295156 1592598846 9781592598847 1280359366 9781280359361

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