Essential CNS Drug Development

Erscheinungsjahr 2012
ISBN: 978-0-521-76606-7
Verlag: Cambridge University Press

Buch, Englisch, 215 Seiten, Format (B × H): 161 mm x 240 mm, Gewicht: 508 g

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.

Autoren/Hrsg.

Kalali, Amir

Preskorn, Sheldon

Kwentus, Joseph

Stahl, Stephen M.

Fachgebiete

• Naturwissenschaften Chemie Chemie Allgemein Pharmazeutische Chemie, Medizinische Chemie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie

Inhaltsverzeichnis

Preface; 1. History of CNS drug development Sheldon H. Preskorn; 2. Regulatory issues Gwen L. Zornberg; 3. Pre-clinical development Alan J. Cross and Frank D. Yocca; 4. Phase I trials: from traditional to newer approaches Matthew Macaluso, Michael Krams and Sheldon H. Preskorn; 5. Phase II development and the path to personalized medicine in CNS disease Douglas E. Feltner and Kenneth R. Evans; 6. CNS drug development – Phase III Judith Dunn, Penny Randall and Amir Kalali; 7. Statistics issues relevant to CNS drug development Craig H. Mallinckrodt, William R. Prucka and Geert Molenberghs; 8. Clinical trials management at company level Nuala Murphy; 9. Clinical trials management at the site level Joseph Kwentus; 10. Medical writing for CNS indications Ginette Nachman; 11. Dissemination of clinical trial information: multiple audiences, multiple formats Leslie Citrome; 12. The importance of treating cognition in schizophrenia and other severe mental illnesses: background, strategies, and findings to date Philip D. Harvey and Richard S. E. Keefe; 13. Leveraging disruptive technologies to drive innovation in CNS clinical drug development Penny Randall, Judith Dunn and Amir Kalali; Index.

Über Autor(innen)

Preskorn, Sheldon
Sheldon Preskorn is Professor and Chairman, Department of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine, Wichita, KS, USA.

Stahl, Stephen M.
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.

Kalali, Amir
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.

Kwentus, Joseph
Joseph Kwentus is Clinical Professor at the University of Mississippi Medical Center, Jackson, MS, USA.