Cardiovascular Safety in Drug Development and Therapeutic Use: New Methodologies and Evolving Regulatory Landscapes
Cardiovascular Safety in Drug Development and Therapeutic Use: New Methodologies and Evolving Regulatory Landscapes
Adis | Pharmacovigilance | Aug 29 2016 | ISBN-10: 3319403451 | 333 pages | pdf | 3.73 mb
Adis | Pharmacovigilance | Aug 29 2016 | ISBN-10: 3319403451 | 333 pages | pdf | 3.73 mb
Authors: Turner, J. Rick, Karnad, Dilip R., Kothari, Snehal
Cutting-edge descriptions and explanations of state-of-the-art cardiovascular safety assessments enable readers to get up to speed quickly. No other book provides such a comprehensive overview of one of the most important topics in drug development and therapeutic use
Early chapters provide discussions of background material to make the book a self-contained, single resource for readers
In addition to the 500 references cited in the book’s chapters, 900 Further Readings are provided for readers, making the book an extremely valuable compendium of research in this field
A special chapter provides a safety perspective on additional aspects of drug development and therapeutic use, placing cardiovascular safety within the larger field of general drug safety
At a time when the field of cardiac safety is going through important changes, this unique book provides the rationale for, and cutting-edge explanations of, new regulatory landscapes that will likely govern cardiac safety assessments globally for the foreseeable future. Exposure-response modeling is already being accepted by regulatory agencies in lieu of the traditional Thorough QT/QTc Study, and the Comprehensive in vitro Proarrhythmia Assay initiative is well under way.
Developments in the field of cardiovascular safety are also described and discussed in the book. These include the search for more efficient ways to exonerate new drugs for type 2 diabetes from an unacceptable cardiovascular liability, how best to address off-target blood pressure increases induced by noncardiovascular drugs, and the continued evolution of the discipline of Cardio-oncology.
Number of Illustrations and Tables
2 illustrations in colour
Topics
Drug Safety and Pharmacovigilance
Cardiology
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