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Cardiac Safety of Noncardiac Drugs Practical Guidelines for Clinical Research and Drug Development
Title
Cardiac Safety of Noncardiac Drugs [electronic resource] : Practical Guidelines for Clinical Research and Drug Development / edited by Joel Morganroth, Ihor Gussak.
ISBN
9781592598847
Edition
1st ed. 2005.
Publication
Totowa, NJ : Humana Press : Imprint: Humana, 2005.
Physical Description
1 online resource (XII, 362 p.)
Local Notes
Access is available to the Yale community.
Access and use
Access restricted by licensing agreement.
Summary
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.
Variant and related titles
Springer ENIN.
Other formats
Printed edition:
Printed edition:
Printed edition:
Format
Books / Online
Language
English
Added to Catalog
October 02, 2019
Contents
Cardiac Safety of Noncardiac Drugs
Preclinical and Pharmacogenomic Cardiac Safety Evaluations
Molecular Physiology of Ion Channels That Control Cardiac Repolarization
Cellular, Molecular, and Pharmacologic Mechanisms Underlying Drug-Induced Cardiac Arrhythmogenesis
hERG Assay, QT Liability, and Sudden Cardiac Death
Pharmacogenomics in Drug Development
Clinical Methodologies and Technical Aspects of Assessing Cardiac Safety of Investigational Drugs: Focus on Cardiac Repolarization
Assessment of Ventricular Repolarization From Body-Surface ECGs in Humans
ECG Acquisition and Signal Processing
Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation
Holter Monitoring for QT
Application of ELectrocardiology in Clinical Research
Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment
Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugs
Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials
Cardiac Arrhythmia Assessment in Phase IV Clinical Studies
Statistical Analysis Plans for ECG Data
Interpretation of Clinical ECG Data
Regulatory COnsiderations
The FDA’s Digital ECG Initiative and Its Impact on Clinical Trials
Quality Control and Quality Assurance for Core ECG Laboratories
ECG Digital Communities and Electronic Reporting of Cardiac Safety Data.
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