![]() ![]() ![]() New Drug Approval Process The FDA and the Food, Drug and Cosmetic Act New Drug Development and Approval: A Brief Overview of the Principal Steps. 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):62-63 368 pp. Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. New Drug Development: A Regulatory Overview Eighth Edition by Mark Mathieu with contributions from. Exposure-response modeling is already being accepted by regulatory agencies in lieu of the traditional Thorough QT/QTc Study, and the Comprehensive in vitroProarrhythmia Assay initiative is well under way.Developments in the field of cardiovascular safety are also described and discussed in the book. Druck auf Anfrage Neuware -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.
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