Skip to main content
SpringerLink
Log in
Book cover

Cardiac Safety of Noncardiac Drugs

Practical Guidelines for Clinical Research and Drug Development

  • Book
  • © 2005

Overview

Editors:
  1. Joel Morganroth

    1. eResearchTechnology Inc., Philadelphia, USA
      University of Pennsylvania School of Medicine, Philadelphia, USA

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

  2. Ihor Gussak

    1. Global Medical Affairs, eResearchTechnology Inc., Bridgewater
      UMDNJ-Robert Wood Johnson Medical School, New Brunswick
      Journal of Electrocardiology, Bridgewater, USA

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

This is a preview of subscription content, log in via an institution to check access.

Access this book

Log in via an institution
eBook USD 129.00
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book USD 169.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book USD 169.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Other ways to access

Licence this eBook for your library

Institutional subscriptions

Table of contents (18 chapters)

  1. Front Matter

    Pages i-xii
    Download chapter PDF

  2. Introduction

    1. Front Matter

      Pages 1-1
      Download chapter PDF

    2. Cardiac Safety of Noncardiac Drugs

      • Raymond John Lipicky
      Pages 3-9

  3. Preclinical and Pharmacogenomic Cardiac Safety Evaluations

    1. Front Matter

      Pages 11-11
      Download chapter PDF

    2. Molecular Physiology of Ion Channels That Control Cardiac Repolarization

      • Jeanne M. Nerbonne, Robert S. Kass
      Pages 13-36

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

      • Charles Antzelevitch
      Pages 37-66

    4. hERG Assay, QT Liability, and Sudden Cardiac Death

      • Arthur M. Brown
      Pages 67-81

    5. Pharmacogenomics in Drug Development

      • Richard Judson, Arthur J. Moss
      Pages 83-103

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

    1. Front Matter

      Pages 105-105
      Download chapter PDF

    2. Assessment of Ventricular Repolarization From Body-Surface ECGs in Humans

      • Jean-Philippe Couderc, Wojciech Zareba
      Pages 107-129

    3. ECG Acquisition and Signal Processing

      • Justin L. Mortara
      Pages 131-145

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

      • Nenad Sarapa
      Pages 147-166

    5. Holter Monitoring for QT

      • Fabio Badilini, Pierre Maison-Blanche
      Pages 167-185

  5. Application of ELectrocardiology in Clinical Research

    1. Front Matter

      Pages 187-187
      Download chapter PDF

    2. Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment

      • Ihor Gussak, Robert Kleiman, Jeffrey S. Litwin
      Pages 189-203

    3. Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugs

      • Joel Morganroth
      Pages 205-222

    4. Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials

      • Martin P. Bedigian
      Pages 223-227

    5. Cardiac Arrhythmia Assessment in Phase IV Clinical Studies

      • Gerald A. Faich, Annette Stemhagen
      Pages 229-237

    6. Statistical Analysis Plans for ECG Data

      • Alan S. Hollister, Timothy H. Montague
      Pages 239-257

    7. Interpretation of Clinical ECG Data

      • Rashmi R. Shah
      Pages 259-298
Back to top

Keywords

About this book

Although it is relatively easy to determine the efficacy of a new drug, it is difficult to establish its safety when administered to millions of patients with multifaceted diseases, co-morbidities, sensitivities, and multiple drug use. In Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development, 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 from their effects on the electrocardiogram (ECG). 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 electrocardiology in clinical research, demonstrating 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 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.
Authoritative and up-to-date, Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development offers clinical researchers in industry and academia expert practical advice on establishing their product's cardiac safety, predicting regulatory actions, and getting it successfully to market.

Reviews

"...excellent and timely...an extremely readable and handy guide to the subject." - BTS Newsletter

Editors and Affiliations

  • eResearchTechnology Inc., Philadelphia, USA

    Joel Morganroth

  • University of Pennsylvania School of Medicine, Philadelphia, USA

    Joel Morganroth

  • Global Medical Affairs, eResearchTechnology Inc., Bridgewater

    Ihor Gussak

  • UMDNJ-Robert Wood Johnson Medical School, New Brunswick

    Ihor Gussak

  • Journal of Electrocardiology, Bridgewater, USA

    Ihor Gussak

Bibliographic Information

  • Book Title: Cardiac Safety of Noncardiac Drugs

  • Book Subtitle: Practical Guidelines for Clinical Research and Drug Development

  • Editors: Joel Morganroth, Ihor Gussak

  • DOI: https://doi.org/10.1007/978-1-59259-884-7

  • Publisher: Humana Totowa, NJ

  • eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)

  • Copyright Information: Humana Press 2005

  • Hardcover ISBN: 978-1-58829-515-6Published: 04 November 2004

  • Softcover ISBN: 978-1-61737-612-2Published: 16 December 2010

  • eBook ISBN: 978-1-59259-884-7Published: 10 October 2007

  • Edition Number: 1

  • Number of Pages: XII, 362

  • Topics: Pharmacology/Toxicology

Publish with us

Policies and ethics

Back to top

Search

Navigation