Cardiac Safety of Noncardiac Drugs

Practical Guidelines for Clinical Research and Drug Development

Editors: Morganroth, Joel, Gussak, Ihor (Eds.)

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eBook $199.00
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  • ISBN 978-1-59259-884-7
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Hardcover $259.00
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  • ISBN 978-1-58829-515-6
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Softcover $259.00
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  • ISBN 978-1-61737-612-2
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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


Table of contents (8 chapters)

  • Molecular Physiology of Ion Channels That Control Cardiac Repolarization

    Jeanne M. Nerbonne PhD, Robert S. Kass PhD

    Pages 13-36

  • hERG Assay, QT Liability, and Sudden Cardiac Death

    Arthur M. Brown MD, PhD

    Pages 67-81

  • Pharmacogenomics in Drug Development

    Richard Judson PhD, Arthur J. Moss MD, FACC

    Pages 83-103

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

    Joel Morganroth MD

    Pages 205-222

  • Cardiac Arrhythmia Assessment in Phase IV Clinical Studies

    Gerald A. Faich MD, MPH, FISPE, Annette Stemhagen DrPH, FISPE

    Pages 229-237

Buy this book

eBook $199.00
price for USA (gross)
  • ISBN 978-1-59259-884-7
  • Digitally watermarked, DRM-free
  • Included format: PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $259.00
price for USA
  • ISBN 978-1-58829-515-6
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $259.00
price for USA
  • ISBN 978-1-61737-612-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
Cardiac Safety of Noncardiac Drugs
Book Subtitle
Practical Guidelines for Clinical Research and Drug Development
Editors
  • Joel Morganroth
  • Ihor Gussak
Copyright
2005
Publisher
Humana Press
Copyright Holder
Humana Press
eBook ISBN
978-1-59259-884-7
DOI
10.1007/978-1-59259-884-7
Hardcover ISBN
978-1-58829-515-6
Softcover ISBN
978-1-61737-612-2
Edition Number
1
Number of Pages
XII, 362
Topics