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Cardiac Safety of Noncardiac Drugs

Practical Guidelines for Clinical Research and Drug Development

  • Joel Morganroth
  • Ihor Gussak

Table of contents

  1. Front Matter
    Pages i-xii
  2. Introduction

    1. Front Matter
      Pages 1-1
    2. Raymond John Lipicky
      Pages 3-9
  3. Preclinical and Pharmacogenomic Cardiac Safety Evaluations

    1. Front Matter
      Pages 11-11
    2. Jeanne M. Nerbonne, Robert S. Kass
      Pages 13-36
    3. 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
    2. Jean-Philippe Couderc, Wojciech Zareba
      Pages 107-129
    3. Justin L. Mortara
      Pages 131-145
    4. Fabio Badilini, Pierre Maison-Blanche
      Pages 167-185
  5. Application of ELectrocardiology in Clinical Research

    1. Front Matter
      Pages 187-187
    2. Ihor Gussak, Robert Kleiman, Jeffrey S. Litwin
      Pages 189-203
    3. Gerald A. Faich, Annette Stemhagen
      Pages 229-237
    4. Alan S. Hollister, Timothy H. Montague
      Pages 239-257
    5. Rashmi R. Shah
      Pages 259-298
  6. Regulatory COnsiderations

    1. Front Matter
      Pages 299-299
  7. Back Matter
    Pages 355-361

About this book

Introduction

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.

Keywords

clinical research clinical trial drug drug development electrocardiogram (ECG) electrocardiography physiology research sudden cardiac death

Editors and affiliations

  • Joel Morganroth
    • 1
    • 2
  • Ihor Gussak
    • 3
    • 4
    • 5
  1. 1.eResearchTechnology Inc.PhiladelphiaUSA
  2. 2.University of Pennsylvania School of MedicinePhiladelphiaUSA
  3. 3.Global Medical AffairseResearchTechnology Inc.Bridgewater
  4. 4.UMDNJ-Robert Wood Johnson Medical SchoolNew Brunswick
  5. 5.Journal of ElectrocardiologyBridgewaterUSA

Bibliographic information