Cardiovascular Safety in Drug Development and Therapeutic Use
New Methodologies and Evolving Regulatory Landscapes
J Rick Turner author Dilip R Karnad author Snehal Kothari author
Format:Paperback
Publisher:Springer International Publishing AG
Published:12th Jun '18
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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.“a resource that will likely serve as a standard for years to come”
- Dr Jonathan Seltzer
Therapeutic Innovation & Regulatory Science, 2017;51(2):180
“I have no hesitation in recommending this book as a valuable reference source”
- Dr Rashmi Shah
Journal for Clinical Studies, 2017;9(1):62-63
“Dr Turner and his colleagues have done the drug development community a service by providing a compendium of cardiovascular safety. They have done a masterful job of placing cardiovascular safety firmly within the context of overall drug development. As such, Cardiovascular Safety in Drug Development and Therapeutic Use is a book that should be on the shelf of every drug developer.” (Jonathan H. Seltzer, Therapeutic Innovation Regulatory Science, Vol. 51 (2), March, 2017)
“This book brings together a wealth of information … state-of-the-art knowledge on the mechanisms involved in drug-induced adverse cardiovascular effects and the investigational strategies available to characterise drugs for these effects. … The authors deserve our congratulations for their immense efforts and well-presented contribution to the scientific community. … It caters for all professionals interested in cardiovascular safety of drugs, including academic, regulatory and pharmaceutical scientists. I have no hesitation in recommending this book as a valuable reference source.” (Dr. Rashmi Shah, Journal for Clinical Studies, Vol. 9 (1), 2017)
“The aim is to provide researchers and clinicians fundamental knowledge in the field of biopharmaceutical cardiovascular safety in a comprehensive manner. This book is written for readers at all levels of involvement with drug development and therapeutic use, from pharmaceutical researchers to pharmacists and physicians. … Impressive features of the book include the extensive references and further reading lists at the end of each chapter … .” (John C. Gulotta, Doody's Book Reviews, November, 2016)
ISBN: 9783319820859
Dimensions: unknown
Weight: unknown
342 pages
Softcover reprint of the original 1st ed. 2017