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New Methodologies and Evolving Regulatory Landscapes
Louise Reader
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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.
“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
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