Integrated Cardiac Safety

Beschreibung

The serious nature of cardiovascular adverse drug reactions occurring in patients makes assessment of a drug's cardiac safety profile a high priority during both development and post-approval monitoring. Integrated Cardiac Safety provides necessary guidance and methodology for professionals assessing cardiac safety of drugs throughout all stages of the drug's life, from discovery and development through postmarketing research. This self-contained, reader-friendly text is valuable to professionals in the pharmaceutical, biotechnology, and CRO industries, pharmacologists, toxicologists, government officials, and students.

Autor*in

J. Rick Turner

Themen in »Integrated Cardiac Safety«

Chemie Chemistry Drug Discovery & Development Medical Science Medizin Pharmaceutical Statistics Pharmacology & Pharmaceutical Medicine Pharmakologie u. Pharmazeutische Medizin Pharmazeutische Statistik Statistics Statistik Wirkstoffforschung u. -entwicklung

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"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 andcomprehensive, providing both historical and prospectiveviewpoints. It provides practical information on drug safetythroughout lifecycle development, from molecular biology topostmarketing surveillance. It will be an invaluable source ofinformation for those who want to learn about this area, as well asfor basic scientists, clinical investigators, physicians, andregulators currently wrestling with the diverse challenges ofcardiac safety." --Peter K.S. Siegl, Ph.D., Siegl Pharma Consulting LLC "At a moment in health care history when public policy and thepractice of medicine are on a collision course and meta-analysismadness threatens to derail 21st century drug development, Turnerand Durham strive to return us to the right path, the CriticalPath, brightly lit by practical advice and sound science. This is atimely and important book." --Peter J. Pitts, PhD, President, Center for Medicine in thePublic Interest, Former Associate Commissioner, FDA "Professors Turner and Durham provide a forward-looking guide tomedication safety issues relevant to all classes ofpharmaceuticals. And their guidance could not be more timely. Thepublic and policymakers are increasingly--andrightly--focused on safety issues at both the development andpostmarketing stages. The authors provide a synthesis of medicationsafety issues that is comprehensive, accessible, and that speaks toa wide range of health care professionals. Integrated CardiacSafety is an important, and welcome, work." --Jay Campbell, JD, RPh, Executive Director, North CarolinaBoard of Pharmacy
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