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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.
Sommario
Part I. Introduction
Cardiac Safety of Noncardiac Drugs: Historical Recollections
Raymond John Lipicky
Part II. Preclinical and Pharmacogenomic Cardiac Safety Evaluations
Molecular Physiology of Ion Channels That Control Cardiac Repolarization
Jeanne M. Nerbonne and Robert S. Kass
Cellular, Molecular, and Pharmacologic Mechanisms Underlying Drug-Induced Cardiac Arrhythmogenesis
Charles Antzelevitch
hERG Assay, QT Liability, and Sudden Cardiac Death
Arthur M. Brown
Pharmacogenomics in Drug Development: When and How to Apply
Richard Judson and Arthur J. Moss
Part III. 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
Jean-Philippe Couderc and Wojciech Zareba
ECG Acquisition and Signal Processing: 12-Lead ECG Acquisition
Justin L. Mortara
Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation: Assessment by Different Recording and Measurement Methods
Nenad Sarapa
Holter Monitoring for QT: The RR Bin Method in Depth
Fabio Badilini and Pierre Maison-Blanche\
Part IV. Application of Electrocardiology in Clinical Research
Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment
Ihor Gussak, Robert Kleiman, and Jeffrey S. Litwin
Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugs
Joel Morganroth
Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials
Martin P. Bedigian
Cardiac Arrhythmia Assessment in Phase IV Clinical Studies
Gerald A. Faich and Annette Stemhagen
Statistical Analysis Plans for ECG Data: Controlling the Intrinsic and Extrinsic Variability in QT Data
Alan S. Hollister and Timothy H Montague
Interpretation of Clinical ECG Data: Understanding the Risk From Non-Antiarrhythmic Drugs
Rashmi R. Shah
Part V. Regulatory Considerations
The FDA's Digital ECG Initiative and Its Impact on Clinical Trials
Barry D. Brown
Quality Control and Quality Assurance for Core ECG Laboratories
Amy M. Annand-Furlong
ECG Digital Communities and Electronic Reporting of Cardiac Safety Data: New Technologies for Reporting Digital ECG Data in Clinical Research Settings
Scott Grisanti and Robert Brown
Index
Testo aggiuntivo
"...excellent and timely...an extremely readable and handy guide to the subject." - BTS Newsletter
