Cardiac Safety of Noncardiac Drugs (eBook)

Part I. Introduction

Cardiac Safety of Noncardiac Drugs: Historical Recollections
Raymond John Lipicky

Part II. Preclinical and Pharmacogenomic Cardiac Safety Evaluations

Molecular Physiology of Ion Channels That Control Cardiac Repolarization
Jeanne M. Nerbonne and Robert S. Kass

Cellular, Molecular, and Pharmacologic Mechanisms Underlying Drug-Induced Cardiac Arrhythmogenesis
Charles Antzelevitch

hERG Assay, QT Liability, and Sudden Cardiac Death
Arthur M. Brown

Pharmacogenomics in Drug Development: When and How to Apply
Richard Judson and Arthur J. Moss

Part III. 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
Jean-Philippe Couderc and Wojciech Zareba

ECG Acquisition and Signal Processing: 12-Lead ECG Acquisition
Justin L. Mortara

Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation: Assessment by Different Recording and Measurement Methods
Nenad Sarapa

Holter Monitoring for QT: The RR Bin Method in Depth
Fabio Badilini and Pierre Maison-Blanche/

Part IV. Application of Electrocardiology in Clinical Research

Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment
Ihor Gussak, Robert Kleiman, and Jeffrey S. Litwin

Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugs
Joel Morganroth

Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials
Martin P. Bedigian

Cardiac Arrhythmia Assessment in Phase IV Clinical Studies
Gerald A. Faich and Annette Stemhagen

Statistical Analysis Plans for ECG Data: Controlling the Intrinsic and Extrinsic Variability in QT Data
Alan S. Hollister and Timothy H Montague

Interpretation of Clinical ECG Data: Understanding the Risk From Non-Antiarrhythmic Drugs
Rashmi R. Shah

Part V. Regulatory Considerations

The FDA's Digital ECG Initiative and Its Impact on Clinical Trials
Barry D. Brown

Quality Control and Quality Assurance for Core ECG Laboratories
Amy M. Annand-Furlong

ECG Digital Communities and Electronic Reporting of Cardiac Safety Data: New Technologies for Reporting Digital ECG Data in Clinical Research Settings
Scott Grisanti and Robert Brown

Index