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

Format:

Book

Contributor:

Morganroth, Joel.

Gussak, Ihor.

Language:

English

Subjects (All):

Cardiovascular toxicology.

Heart--Effect of drugs on.

Heart.

Drugs--Side effects--Testing.

Drugs.

Electrocardiography.

Heart--drug effects.

Drug-Related Side Effects and Adverse Reactions.

Drugs--Side effects.

Testing.

Medical Subjects:

Heart--drug effects.

Drug-Related Side Effects and Adverse Reactions.

Physical Description:

xii, 361 pages : illustrations (some color) ; 26 cm

Place of Publication:

Totowa, N.J. : Humana Press, [2005]

Contents:

Chapter 1 Cardiac Safety of Noncardiac Drugs: Historical Recollections / Raymond John Lipicky 3

Part II Preclinical and Pharmacogenomic Cardiac Safety Evaluations

Chapter 2 Molecular Physiology of Ion Channels That Control Cardiac Repolarization / Jeanne M. Nerbonne, Robert S. Kass 13

Chapter 3 Cellular, Molecular, and Pharmacologic Mechanisms Underlying Drug-Induced Cardiac Arrhythmogenesis / Charles Antzelevitch 37

Chapter 4 hERG Assay, QT Liability, and Sudden Cardiac Death / Arthur M. Brown 67

Chapter 5 Pharmacogenomics in Drug Development: When and How to Apply / Richard Judson, Arthur J. Moss 83

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

Chapter 6 Assessment of Ventricular Repolarization From Body-Surface ECGs in Humans / Jean-Philippe Couderc, Wojciech Zareba 107

Chapter 7 ECG Acquisition and Signal Processing: 12-Lead ECG Acquisition / Justin L. Mortara 131

Chapter 8 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 147

Chapter 9 Holter Monitoring for QT: The RR Bin Method in Depth / Fabio Badilini, Pierre Maison-Blanche 167

Part IV Application of Electrocardiology in Clinical Research

Chapter 10 Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment / Ihor Gussak, Robert Kleiman, Jeffrey S. Litwin 189

Chapter 11 Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugs / Joel Morganroth 205

Chapter 12 Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials / Martin P. Bedigian 223

Chapter 13 Cardiac Arrhythmia Assessment in Phase IV Clinical Studies / Gerald A. Faich, Annette Stemhagen 229

Chapter 14 Statistical Analysis Plans for ECG Data: Controlling the Intrinsic and Extrinsic Variability in QT Data / Alan S. Hollister, Timothy H Montague 239

Chapter 15 Interpretation of Clinical ECG Data: Understanding the Risk From Non-Antiarrhythmic Drugs / Rashmi R. Shah 259

Part V Regulatory Considerations

Chapter 16 The FDA's Digital ECG Initiative and Its Impact on Clinical Trials / Barry D. Brown 301

Chapter 17 Quality Control and Quality Assurance for Core ECG Laboratories / Amy M. Annand-Furlong 329

Chapter 18 ECG Digital Communities and Electronic Reporting of Cardiac Safety Data: New Technologies for Reporting Digital ECG Data in Clinical Research Settings / Scott Grisanti, Robert Brown 339.

Notes:

Includes bibliographical references and index.

ISBN:

158829515X

OCLC:

55729829