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Doody's Review ServiceReviewer: Surya M Artham, MD, MPH (Ochsner Clinic Foundation)
Description: This book nicely summarizes the importance of cardiac safety of drugs in the development process, pre-approval safety clinical trials, and post-approval surveillance.
Purpose: The prime objective of this book is to provide an overview of the steps involved in the approval of investigational agents, their associated cardiac safety issues, preclinical and clinical safety, and efficacy trials with these agents.
Audience: It is intended for pharmacists, clinical researchers, physicians, nurses, students, and allied healthcare professionals. It will be valuable to cardiovascular (CV) specialists and researchers interested in CV safety of cardiac and noncardiac therapeutic agents. The authors are well known and respected authorities in the field of clinical research in pharmacy.
Features: The book systematically highlights the steps involved in the approval of investigational agents for the market, specifically emphasizing the safety of these therapeutic agents on cardiac arrhythmias, generalized cardiac safety, and behavioral cardiac safety. The authors provide an in-depth review of the genetic pathways and other possible underlying mechanisms mediating adverse reactions of therapeutic agents. The book also covers the statistical methodologies applied in clinical trials, gives examples of some major CV drugs, and how and why they were taken off the market due to their adverse side effect profile. A noteworthy feature of this book is the way the authors cover the basics of all-important topics at the beginning of each chapter, making it easy to understand for newcomers in this field.
Assessment: This fills the void for a book addressing the safety issues, especially cardiac safety issues, of therapeutic agents in development. The content is high yield, easy to understand and succinct, covering the multiple steps involved in the drug safety and approval process.