Essential CNS Drug Development
Amir Kalali · Sheldon Preskorn · Joseph Kwentus · Stephen M. Stahl
Jun. 2012 · Cambridge University Press
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Central Nervous System disorders have an enormous impact on individuals and on society as a whole. The development of better treatments is crucial and is a major focus of pharmaceutical and biotechnology companies. This book explains the complicated process of CNS drug development in a way that is engaging for any interested professional or student. Chapters cover each stage of drug development, from pre-clinical research through all phases of clinical trials, to reporting to the regulatory authorities. Other key issues covered include strategic considerations, regulatory constraints, dissemination of results and ethical considerations. The user-friendly format and style enable readers to find important information quickly and easily. Written and edited by experts from different sectors actively engaged in CNS drug development, this is a unique resource for drug developers, investigators, academics and clinicians.
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Amir Kalali is Vice President, Medical and Scientific Services, and Global Therapeutic Team Leader (CNS) at Quintiles Inc. He is also Professor of Psychiatry at the University of California San Diego, San Diego, CA, USA.
Sheldon Preskorn is Professor and Chairman, Department of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine, Wichita, KS, USA.
Joseph Kwentus is Clinical Professor at the University of Mississippi Medical Center, Jackson, MS, USA.
Stephen M. Stahl is Adjunct Professor of Psychiatry at the University of California San Diego, San Diego, and the Neuroscience Education Institute, Carlsbad, CA, USA.
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