Cardiovascular Safety in Drug Development and Therapeutic Use
New Methodologies and Evolving Regulatory Landscapes
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Beschreibung
With the advent of multiple new therapeutic agents for a variety of important diseases has come an increasing realization that many of these drugs can have adverse effects on the heart and vascular system. As this book so elegantly details the mechanisms by which harm occurs are highly complex, many times predictable, but always clinically relevant.
Notable experts in the field of cardiovascular medicine, such as Drs. Turner, Karnad, and Kothari, have turned their attention to this thorny problem, and begun to dissect the diverse mechanisms by which cardiac harm can occur with a variety of non-cardiac drugs. This is no easy task, given the complexity of the diseases we treat, and the wide spectrum of new therapies we seek to apply. However, it is an issue with which all health care providers must become familiar in order to prescribe appropriate therapy while safeguarding patients against avoidable and life-threatening cardiac adverse effects.
This compendium represents the state-of-the-art in the evolving field of cardiac safety and is vital reading for those interested in developing new chemical entities, as well as those who prescribe them and monitor patients for their hazard. As such, I recommend this book as essential reading for students, scientists, and health care providers at all levels of training.
Peter R. Kowey, MD, FACC, FAHA, FHRS
Lankenau Institute for Medical Research & Thomas Jefferson University
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 SeltzerTherapeutic Innovation & Regulatory Science, 2017;51(2):180“I have no hesitation in recommending this book as a valuable reference source” - Dr Rashmi ShahJournal for Clinical Studies, 2017;9(1):62-63
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
Autor*in
J. Rick Turner
Themen in »Cardiovascular Safety in Drug Development and Therapeutic Use«
Proarrhythmic liability QT interval prolongation hERG channel blockade Thorough QT/QTc Study Regulatory science Exposure-response modeling CiPA Cardio-oncology Type 2 diabetes Meta-analysis Postmarketing surveillance Reporting clinical trials
Stimmen zu »Cardiovascular Safety in Drug Development and Therapeutic Use«
“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)
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