Essential CNS drug development
By: edited by Amir Kalali ... [et al.].
Publisher: Cambridge University Press
Published: 2012
Place of publication: Cambridge
Language: eng
Number of pages: 207
ISBN-13: 9780521766067
Subjects: Central Nervous System Agents; Methods; Pharmacology; Drug Evaluation; Preclinical Drug Evaluation; Clinical Trials as Topic
Description: "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.
Notes: Includes bibliographical references and index.
Table of contents: title: Machine generated contents note: History of CNS drug development / Sheldon H. Preskorn; title: Regulatory issues / Gwen L. Zornberg; title: Pre-clinical development / Alan J. Cross and Frank D. Yocca; title: Phase I trials: from traditional to newer approaches / Matthew Macaluso, Michael Krams and Sheldon H. Preskorn; title: Phase II development and the path to personalized medicine in CNS disease / Douglas E. Feltner and Kenneth R. Evans; title: 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; title: Clinical trials management at company level / Nuala Murphy; title: Clinical trials management at the site level / Joseph Kwentus; title: Medical writing for CNS indications / Ginette Nachman; title: Dissemination of clinical trial information: multiple audiences, multiple formats / Leslie Citrome; title: 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; title: Leveraging disruptive technologies to drive innovation in CNS clinical drug development / Penny Randall, Judith Dunn and Amir Kalali.