Cardiovascular Safety in Drug Development and Therapeutic Use

New Methodologies and Evolving Regulatory Landscapes

  • J. Rick Turner
  • Dilip R. Karnad
  • Snehal Kothari

Table of contents

  1. Front Matter
    Pages i-xxvi
  2. Introduction

    1. Front Matter
      Pages 1-1
    2. J. Rick Turner, Dilip R. Karnad, Snehal Kothari
      Pages 3-20
  3. A Primer of Biological and Physiological Considerations

    1. Front Matter
      Pages 21-21
    2. J. Rick Turner, Dilip R. Karnad, Snehal Kothari
      Pages 23-49
    3. J. Rick Turner, Dilip R. Karnad, Snehal Kothari
      Pages 51-70
  4. A Primer of Statistical Considerations

    1. Front Matter
      Pages 71-71
    2. J. Rick Turner, Dilip R. Karnad, Snehal Kothari
      Pages 73-98
    3. J. Rick Turner, Dilip R. Karnad, Snehal Kothari
      Pages 99-113
  5. Proarrhythmic Cardiac Safety

    1. Front Matter
      Pages 135-135
    2. J. Rick Turner, Dilip R. Karnad, Snehal Kothari
      Pages 181-197
  6. Additional Domains of Cardiovascular Safety

    1. Front Matter
      Pages 199-199
    2. J. Rick Turner, Dilip R. Karnad, Snehal Kothari
      Pages 201-221
    3. J. Rick Turner, Dilip R. Karnad, Snehal Kothari
      Pages 223-238
  7. Additional Considerations in General Drug Safety and Therapeutic Use

    1. Front Matter
      Pages 277-277

About this book

Introduction

With the advent of multiple new therapeutic agents for a variety of important diseases has come an increasing realization that many of these drugs can have adverse effects on the heart and vascular system. As this book so elegantly details the mechanisms by which harm occurs are highly complex, many times predictable, but always clinically relevant.

Notable experts in the field of cardiovascular medicine, such as Drs. Turner, Karnad, and Kothari, have turned their attention to this thorny problem, and begun to dissect the diverse mechanisms by which cardiac harm can occur with a variety of non-cardiac drugs. This is no easy task, given the complexity of the diseases we treat, and the wide spectrum of new therapies we seek to apply. However, it is an issue with which all health care providers must become familiar in order to prescribe appropriate therapy while safeguarding patients against avoidable and life-threatening cardiac adverse effects.

This compendium represents the state-of-the-art in the evolving field of cardiac safety and is vital reading for those interested in developing new chemical entities, as well as those who prescribe them and monitor patients for their hazard. As such, I recommend this book as essential reading for students, scientists, and health care providers at all levels of training.

Peter R. Kowey, MD, FACC, FAHA, FHRS

Lankenau Institute for Medical Research & Thomas Jefferson University

Keywords

Proarrhythmic liability QT interval prolongation hERG channel blockade Thorough QT/QTc Study Regulatory science Exposure-response modeling CiPA Cardio-oncology Type 2 diabetes Meta-analysis Postmarketing surveillance Reporting clinical trials

Authors and affiliations

  • J. Rick Turner
    • 1
  • Dilip R. Karnad
    • 2
  • Snehal Kothari
    • 3
  1. 1.Chief Scientific Advisor, Cardiac Safety ServicesQuintilesDurhamUSA
  2. 2.Head, Research Team, Cardiac Safety ServicesQuintilesMumbaiIndia
  3. 3.Chief Medical & Scientific Officer, Cardiac Safety Services, Global Head, Cardiac Safety Center of ExcellenceQuintilesMumbaiIndia

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-319-40347-2
  • Copyright Information Springer International Publishing Switzerland 2017
  • Publisher Name Adis, Cham
  • eBook Packages Medicine
  • Print ISBN 978-3-319-40345-8
  • Online ISBN 978-3-319-40347-2
  • About this book
Industry Sectors
Biotechnology
Consumer Packaged Goods
Pharma