Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance

“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.” (Doody's, April 2009)

"Turner and Durham’s book is well-organized and comprehensive, providing both historical and prospective viewpoints. It provides practical information on drug safety throughout lifecycle development, from molecular biology to postmarketing surveillance. It will be an invaluable source of information for those who want to learn about this area, as well as for basic scientists, clinical investigators, physicians, and regulators currently wrestling with the diverse challenges of cardiac safety."
—Peter K.S. Siegl, Ph.D., Siegl Pharma Consulting LLC

"At a moment in health care history when public policy and the practice of medicine are on a collision course and meta-analysis madness threatens to derail 21st century drug development, Turner and Durham strive to return us to the right path, the Critical Path, brightly lit by practical advice and sound science. This is a timely and important book."
—Peter J. Pitts, PhD, President, Center for Medicine in the Public Interest, Former Associate Commissioner, FDA

"Professors Turner and Durham provide a forward-looking guide to medication safety issues relevant to all classes of pharmaceuticals. And their guidance could not be more timely. The public and policymakers are increasingly—and rightly—focused on safety issues at both the development and postmarketing stages. The authors provide a synthesis of medication safety issues that is comprehensive, accessible, and that speaks to a wide range of health care professionals. Integrated Cardiac Safety is an important, and welcome, work."
—Jay Campbell, JD, RPh, Executive Director, North Carolina Board of Pharmacy