Morganroth / Gussak Cardiac Safety of Noncardiac Drugs

Practical Guidelines for Clinical Research and Drug Development
1. Auflage 2007
ISBN: 978-1-59259-884-7
Verlag: Humana Press
Format: PDF
Kopierschutz: 1 - PDF Watermark

E-Book, Englisch, 362 Seiten, eBook

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. 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 electrocardiography in clinical research, 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 ECG 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.

Zielgruppe

Professional/practitioner

Autoren/Hrsg.

Morganroth, Joel

Gussak, Ihor

Inhaltsverzeichnis

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.