Overview
- Editors:
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Joel Morganroth
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eResearchTechnology Inc., Philadelphia, USA
University of Pennsylvania School of Medicine, Philadelphia, USA
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Ihor Gussak
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Global Medical Affairs, eResearchTechnology Inc., Bridgewater
UMDNJ-Robert Wood Johnson Medical School, New Brunswick
Journal of Electrocardiology, Bridgewater, USA
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Table of contents (18 chapters)
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Regulatory COnsiderations
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Front Matter
Pages 299-299
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- Scott Grisanti, Robert Brown
Pages 339-354
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Back Matter
Pages 355-361
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
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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