Cambridge University PressEdition: Illustrated, 6/7/2012EAN 9780521766067, ISBN10: 0521766060Hardcover, 215 pages, 24.1 x 16 x 1.5 cmLanguage: EnglishCentral 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.Preface1. History of CNS drug development Sheldon H. Preskorn2. Regulatory issues Gwen L. Zornberg3. Pre-clinical development Alan J. Cross and Frank D. Yocca4. Phase I trialsfrom traditional to newer approaches Matthew Macaluso, Michael Krams and Sheldon H. Preskorn5. Phase II development and the path to personalized medicine in CNS disease Douglas E. Feltner and Kenneth R. Evans6. CNS drug development – Phase III Judith Dunn, Penny Randall and Amir Kalali7. Statistics issues relevant to CNS drug development Craig H. Mallinckrodt, William R. Prucka and Geert Molenberghs8. Clinical trials management at company level Nuala Murphy9. Clinical trials management at the site level Joseph Kwentus10. Medical writing for CNS indications Ginette Nachman11. Dissemination of clinical trial informationmultiple audiences, multiple formats Leslie Citrome12. The importance of treating cognition in schizophrenia and other severe mental illnessesbackground, strategies, and findings to date Philip D. Harvey and Richard S. E. Keefe13. Leveraging disruptive technologies to drive innovation in CNS clinical drug development Penny Randall, Judith Dunn and Amir KalaliIndex.
