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November 16, 2011 | History

Essential CNS drug development 1 edition

Essential CNS drug development
Amir Kalali

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Essential CNS drug development
edited by Amir Kalali ... [et al.].

Published 2012 by Cambridge University Press in Cambridge .
Written in English.

About the Book

"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"--Provided by publisher.

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.

Edition Notes

Includes bibliographical references and index.


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History Created November 16, 2011 · 1 revision Download catalog record: RDF / JSON

November 16, 2011 Created by LC Bot import new book