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Clinical Trials in the Neurosciences - 9783805590235

Un libro in lingua di Woodbury harris K. M. (EDT), Coull B. M. (EDT) edito da S Karger Pub, 2009

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For neurologists, neurosurgeons, and other clinician researchers, this volume contains 34 chapters that detail how to translate preclinical studies to clinical trials in neurology and neurosurgery. Woodbury-Harris, a clinical trials and neuroscience consultant, and Coull (neurology, U. of Arizona Health Science Center) compile chapters by neurologists, neuroscientists, and other researchers from the US and France, who discuss animal models of various neurological diseases, FDA and European requirements, translation and scaling up from animal to human studies, the design of phase I, II, III, and multicenter trials, and the use of biomarkers as surrogate endpoints. A section on phase III trials also covers clinical endpoints and data management and quality. Topics relating to multicenter trials--recruiting special populations, monitoring, and ethical and consent issues--are included, as are genetics, gene therapy, imaging, and surgical devices. Annotation ©2009 Book News, Inc., Portland, OR (booknews.com)

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