Essential CNS drug developmentcedited

• Other Authors: Kalali, Amir (Editor), Preskorn, Sheldon (Editor), Kwentus, Joseph (Editor), Stahl, Stephen M. (Editor)
• Format: Book
• Language: English
• Published: Cambridge Cambridge University Press 2012
• Series: Cambridge medicine
• Subjects: Central Nervous System Agents > pharmacology; Clinical Trials as Topic > methods; Drug Evaluation > methods; Drug Evaluation, Preclinical > methods
• Online Access: Click Here to View Status and Holdings.

"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 tha...

Table of Contents:

• Machine generated contents note: History of CNS drug development / Sheldon H. Preskorn
• Regulatory issues / Gwen L. Zornberg
• Pre-clinical development / Alan J. Cross and Frank D. Yocca
• Phase I trials: from traditional to newer approaches / Matthew Macaluso, Michael Krams and Sheldon H. Preskorn
• Phase II development and the path to personalized medicine in CNS disease / Douglas E. Feltner and Kenneth R. Evans
• CNS drug development - Phase III / Judith Dunn, Penny Randall and Amir Kalali / Statistics issues relevant to CNS drug development / Craig H. Mallinckrodt, William R. Prucka and Geert Molenberghs
• Clinical trials management at company level / Nuala Murphy
• Clinical trials management at the site level / Joseph Kwentus
• Medical writing for CNS indications / Ginette Nachman
• Dissemination of clinical trial information: multiple audiences, multiple formats / Leslie Citrome
• 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
• Leveraging disruptive technologies to drive innovation in CNS clinical drug development / Penny Randall, Judith Dunn and Amir Kalali.