By: Amir Kalali (Editor), Joseph Kwentus (Editor), Loren Friedman (Editor), Sheldon H. Preskorn (Editor), Stephen M. Stahl (Editor)

Hardcover

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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.

Preface
History of CNS drug development
Regulatory issues
Pre-clinical development
Phase I trials: from traditional to newer approaches
Phase II development and the path to personalized medicine in CNS disease
CNS drug development - Phase III
Statistics issues relevant to CNS drug development
Clinical trials management at company level
Clinical trials management at the site level
Medical writing for CNS indications
Dissemination of clinical trial information: multiple audiences, multiple formats
The importance of treating cognition in schizophrenia and other severe mental illnesses: background, strategies, and findings to date
Leveraging disruptive technologies to drive innovation in CNS clinical drug development
Index
Table of Contents provided by Publisher. All Rights Reserved.

ISBN: 9780521766067
ISBN-10: 0521766060
Audience: Professional
Format: Hardcover
Language: English
Number Of Pages: 218
Published: 7th June 2012
Dimensions (cm): 23.4 x 16.2  x 1.9
Weight (kg): 0.52