Spis treści
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.- h ERG 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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