vbid/9783319403472

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):62-63Typham this is the title: Cardiovascular Safety in Drug Development and Therapeutic Use New Methodologies and Evolving Regulatory Landscapes