Cardiac Safety of Noncardiac Drugs (eBook)

Practical Guidelines for Clinical Research and Drug Development

Joel Morganroth, Ihor Gussak (Herausgeber)

eBook Download: PDF

2007 | 2005
XII, 362 Seiten
Humana Press (Verlag)
978-1-59259-884-7 (ISBN)

Infos

Basic and clinical researchers from industry and academia detail the preclinical, clinical, and regulatory principles currently used to assess the cardiac safety of new drugs. The authors explain the parameters of cardiac safety at all stages of clinical research and drug development, including both the preclinical and pharmacogenomic aspects generally and the clinical methodologies and technical aspects for investigational drugs based on cardiac repolarization, as defined by the duration of the QTc interval. Additional chapters comprehensively review the application of electrocardiography in clinical research, the fundamentals of ECG interpretation in clinical trials, the statistical analysis plans for ECG data obtained in formal clinical trials, and the practical interpretation of the ECG results. Highlights include practical guidance on how to conduct a thorough ECG Trial in New Drug Development, how to use new ECG and web based technology in clinical research, and how to follow the new FDA requirements for ECG submissions.

Inhalt

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

Produkt-Details

• Erscheint lt. Verlag: 10.10.2007
• Zusatzinfo: XII, 362 p.
• Verlagsort: Totowa
• Sprache: englisch
• Themenwelt: Medizinische Fachgebiete ► Innere Medizin ► Kardiologie / Angiologie
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
• Themenwelt: Medizin / Pharmazie ► Pharmazie
• Themenwelt: Studium ► 1. Studienabschnitt (Vorklinik) ► Biochemie / Molekularbiologie
• Schlagworte: clinical research • clinical trial • Drug • drug development • electrocardiogram (ECG) • Electrocardiography • Physiology • Research • sudden cardiac death
• ISBN-10: 1-59259-884-6 / 1592598846
• ISBN-13: 978-1-59259-884-7 / 9781592598847