Cardiovascular Safety in Drug Development and Therapeutic Use (eBook)

New Methodologies and Evolving Regulatory Landscapes

J. Rick Turner, Dilip R. Karnad, Snehal Kothari (Autoren)

eBook Download: PDF

2016 | 1st ed. 2017
XXVI, 342 Seiten
Springer International Publishing (Verlag)
978-3-319-40347-2 (ISBN)

Infos

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.

J. Rick Turner, BSc (Hons), PGCE, PhD, DSc, is an experimental research scientist, clinical trialist, author, editor, and educator.  He spent the first part of his professional career in the field of Cardiovascular Behavioral Medicine, detailing the individual differences apparent in cardiovascular responses to behavioral and psychological stressors, including genetic influences upon them.  He received two international awards for his research, and is Co-Editor of the 2013 Springer volume Encyclopedia of Behavioral Medicine, the definitive work in this area.

Dr Turner is currently Chief Scientific Advisor, Cardiac Safety Services, and Senior Scientific Director, Clinical Communications, Quintiles.  He is also member of Quintiles' Cardiovascular and Diabetes Centers of Excellence.  He is the author and co-author of over 120 publications in peer-reviewed journals, and the author, co-author,and editor of 15 books.  Additionally, he holds the positions of Adjunct Professor of Pharmacy Practice, Campbell University College of Pharmacy & Health Sciences, and President and Chief Scientific Officer, Turner Medical Communications.

Dilip R. Karnad, MD, FACP, FRCP (Glasg), is an internist and an expert in cardiac safety with extensive clinical, research and teaching experience.  He is currently Head of the Research Team, Cardiac Safety Services, Quintiles.  He has a particular interest in statistical approaches to cardiac safety assessments, and has published over 20 papers in this field.  He is a Fellow of the America College of Physicians and a Fellow of the Royal College of Physicians (of Glasgow), and also a practicing internist affiliated to Lilavati Hospital &Research Centre, Mumbai.

Snehal Kothari, MD, DM, FACC, FESC is a cardiologist and an expert in cardiac safety with extensive clinical, research and teaching experience.  He is currently Chief Medical & Scientific Officer of the Core ECG Laboratory, Cardiac Safety Services, and Global Head of the Cardiac Safety Centre of Excellence, Quintiles. He is also a practicing Interventional Cardiologist affiliated to Lilavati Hospital &Research Centre, Mumbai. He is the recipient of over 30 awards and honors, and is a Fellow of the American College of Cardiology, the European Society of Cardiology, and the Asian Pacific Society of Cardiology.  He has over 80 peer-reviewed publications and published abstracts.

Autor

J. Rick Turner, BSc (Hons), PGCE, PhD, DSc, is an experimental research scientist, clinical trialist, author, editor, and educator.  He spent the first part of his professional career in the field of Cardiovascular Behavioral Medicine, detailing the individual differences apparent in cardiovascular responses to behavioral and psychological stressors, including genetic influences upon them.  He received two international awards for his research, and is Co-Editor of the 2013 Springer volume Encyclopedia of Behavioral Medicine, the definitive work in this area.Dr Turner is currently Chief Scientific Advisor, Cardiac Safety Services, and Senior Scientific Director, Clinical Communications, Quintiles.  He is also member of Quintiles’ Cardiovascular and Diabetes Centers of Excellence.  He is the author and co-author of over 120 publications in peer-reviewed journals, and the author, co-author,and editor of 15 books.  Additionally, he holds the positions of Adjunct Professor of Pharmacy Practice, Campbell University College of Pharmacy & Health Sciences, and President and Chief Scientific Officer, Turner Medical Communications.Dilip R. Karnad, MD, FACP, FRCP (Glasg), is an internist and an expert in cardiac safety with extensive clinical, research and teaching experience.  He is currently Head of the Research Team, Cardiac Safety Services, Quintiles.  He has a particular interest in statistical approaches to cardiac safety assessments, and has published over 20 papers in this field. He is a Fellow of the American College of Physicians and a Fellow of the Royal College of Physicians (of Glasgow), and also a practicing internist and critical care physician affiliated to Jupiter Hospital, Thane.Snehal Kothari, MD, DM, FACC, FESC is a cardiologist and an expert in cardiac safety with extensive clinical, research and teaching experience.  He is currently Chief Medical & Scientific Officer of the Core ECG Laboratory, Cardiac Safety Services, and Global Head of the Cardiac Safety Centre of Excellence, Quintiles. He is also a practicing Interventional Cardiologist affiliated to Lilavati Hospital & Research Centre, Mumbai. He is the recipient of over 30 awards and honors, and is a Fellow of the American College of Cardiology, the European Society of Cardiology, and the Asian Pacific Society of Cardiology.  He has over 80 peer-reviewed publications and published abstracts.

Inhalt

The Central Importance of Cardiovascular Safety in Contemporary New Drug Development.- The Biological Basis of Drug Responses.- Cardiovascular Structure, Function, Pathophysiology, & Disease.- The Current Regulatory Landscape.- The "Comprehensive In Vitro Proarrhythmia Assay" Initiative.- The "Early ECG Assessment" Initiative.- The "Submission of Extended Digital ECG Data" Initiative.- Meta-analysis and Meta-methodology.- Current Regulatory Landscapes and their Potential Evolution.- Off-target Blood Pressure Responses to Non-cardiovascular Drugs.- Oncology Drug Development and Therapeutics: Cardiotoxicity Considerations.- Postmarketing Surveillance.- Regulatory Perspectives on General Drug Safety.- Future Directions in Cardiovascular Safety.- References.

Produkt-Details

• Erscheint lt. Verlag: 28.7.2016
• Zusatzinfo: XXVI, 342 p. 2 illus. in color.
• Verlagsort: Cham
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Pharmazie
• Schlagworte: Cardio-Oncology • CiPA • Exposure-response modeling • hERG channel blockade • Meta-analysis • Postmarketing Surveillance • Proarrhythmic liability • QT interval prolongation • Regulatory science • Reporting clinical trials • Thorough QT/QTc Study • type 2 diabetes
• ISBN-10: 3-319-40347-8 / 3319403478
• ISBN-13: 978-3-319-40347-2 / 9783319403472