3 Review(s)

Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development is designed to present the current preclinical, clinical, and regulatory principles to assess the cardiac safety of new drugs based primarily on their effects on the ECG. Practical guidance to define cardiac safety at all stages of clinical research and drug development are featured and discussed by internationally recognized experts with academic, industrial, and regulatory experience. Part 1 of the book contains a historical overview from a clinical and regulatory prospective. Part 2 is devoted to preclinical and pharmacogenomic aspects of cardiac safety in clinical research and development. Part 3 includes clinical methodologies and technical aspects of assessing cardiac safety of investigational drugs with the main focus on cardiac repolarization. Part 4 provides a comprehensive review of the application of electrocardiology in clinical research, while Part 5 presents a broad spectrum of domestic and international regulatory aspects in assessing the cardiac safety in clinical research and drug development.