Critical Pathways to Success in CNS Drug

Clinical Pathways to Success in CNS Drug Development provides a thorough overview of the critical early CNS drug development process for clinical scientists and reviews the latest models, technologies and regulations designed to improve and expedite the drug development process on each of the major CNS disorders. It includes a critical analysis of the lack of CNS specific drugs successfully brought to market and the steps required to remedy this problem. The book covers all of the initial stages of CNS drug development, from pre-clinical to early clinical trials, and includes all the latest technologies, methods, biomarkers, models and regulations designed to accelerate the early CNS drug development process, reduce overall costs, and improve drug safety and efficacy. It also discusses the many inherent difficulties in developing CNS-specific drugs, and describes the many technical and methodological advances used to circumvent these difficulties.

Dr. Neal R. Cutler, Founder and Chairman of Worldwide Clinical Trials, Inc. Previous positions include Deputy Clinical Director of the National Institute on Aging, and Chief, Section on Brain Aging and Dementia. He is currently President of the American Foundation for Clinical Pharmacology.

Dr. John J. Sramek, Director of Clinical Research at Alamo Pharmaceuticals.

Dr Michael F. Murphy, Chief Medical and Scientific Officer, Worldwide Clinical Trials, Inc.

Dr Henry J. Riordan, Senior Vice President, Medical and Scientific Affairs, Worldwide Clinical Trials, Inc.

Dr Peter Biek, Department of Clinical Research, Worldwide Clinical Trials

Dr Angelico Carta, Cedra Clinical Research LLC

Acknowledgments	p. vi
Foreword	p. vii
The impending crisis in CNS drug development	p. 1
Animal models and procedures for CNS disorders	p. 14
Preclinical antecedents to early human clinical trials	p. 70
Biomarkers and surrogate markers in drug development	p. 101
Neuroimaging and cognitive assessments in early drug development	p. 167
Bridging and CSF studies	p. 187
A case study from preclinical to early clinical trials	p. 230
Index	p. 254
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Critical Pathways to Success in CNS Drug Development

Summary

Author Biography

Table of Contents

Supplemental Materials