Full Description
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
Contents
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.
