Cardiac Safety of Noncardiac Drugs

I.Introduction

1. Cardiac Safety of Noncardiac Drugs
Raymond John Lipicky

Part II.Preclinical and Pharmacogenomic Cardiac Safety Evaluations

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

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

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

5. Pharmacogenomics in Drug Development
Richard Judson, Arthur J. Moss

Part III.Clinical Methodologies and Technical Aspects of Assessing Cardiac Safety of Investigational Drugs: Focus on Cardiac Repolarization

6. Assessment of Ventricular Repolarization From Body-Surface ECGs in Humans
Jean-Philippe Couderc, Wojciech Zareba

7. ECG Acquisition and Signal Processing
Justin L. Mortara

8. Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation
Nenad Sarapa

9. Holter Monitoring for QT
Fabio Badilini, Pierre Maison-Blanche

Part IV.Application of ELectrocardiology in Clinical Research

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

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

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

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

14. Statistical Analysis Plans for ECG Data
Alan S. Hollister, Timothy H. Montague

15. Interpretation of Clinical ECG Data
Rashmi R. Shah

Part V.Regulatory COnsiderations

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

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

18. ECG Digital Communities and Electronic Reporting of Cardiac Safety Data
Scott Grisanti, Robert Brown

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Nyckelord: TECHNOLOGY & ENGINEERING / Biomedical TEC059000