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| HANDBOOK OF NEUROEMERGENCY CLINICAL TRIALS
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Edited By
Wayne Alves, Valeant Pharmaceuticals Inc., Costa Mesa, CA, USA
Brett Skolnick, Novo Nordisk Pharmaceuticals, Inc., Princeton, NJ, USA
Description
During the 1990's, scientific advances in understanding the mechanisms and pathophysiology of acute central nervous system injury were
offset by a history of disappointing results from Phase III clinical trials of novel neuroprotective drugs. Numerous novel compounds
were ?tested,? and seemingly fell by the wayside. This book is intended to focus on novel therapies and the unique challenges their intended
targets pose for the design and analysis of clinical trials. The authors explore the issues facing research in this area and the strategies
that might lead to future success in this critical area of unmet medical need. It represents a compendium of information gained from
over 20 years of clinical trial experience in areas of acute neurology and neurosurgery. From the knowledge of clinical assessment using
standardized tools, to the intricate design of difficult hyper-acute neuroemergencies trials, the reader will benefit from the authors'
perspectives.
Audience
Researchers involved with the design of neuroemergency clinical trials, at research labs in universities, hospitals, major pharmaceutical
(e.g., Astra Zeneca, GSK), biotechnology companies involved in these clinical areas.
Contents
STROKE AND TRAUMA
1. Acute Ischemic Stroke (Christopher Bladin, Stephen Davis)
2. Subarachnoid Hemorrhage (Nader Pouratian, Aaron
S. Dumont, Neal F. Kassell)
3. Spontaneous Intracerebral Hemorrhage (Michael D. Hill)
4. Traumatic Brain Injury (Lawrence F.
Marshall, Wayne Alves)
CENTRAL NERVOUS SYSTEM EMERGENCIES
5. Acute Seizures and Status Epilepticus (Susan T. Herman)
6. Clinical
Trials in Neuro-opthamology (Laura Balcer, Madhura A. Tamhankar)
7. Brain Resuscitation (Edwin M. Nemoto)
8. Clinical Trials in Brain
Injury after Cardiac Arrest (Romergryko G. Geocadin, Daniel F. Hanley)
SPECIAL ISSUES IN ACUTE NEUROSCIENCE CLINICAL TRIALS
9. Efficient
Dose-Response Finding Strategies for Acute Neuroemergency Treatments (Tom Parke, Michael Krams, Peter Mueller, Don Berry)
10. Biostatistical
Issues in Neuroemergency Clinical Trials (Wayne M. Alves)
11. Data and Safety Monitoring Boards (Brett Skolnick)
12. Role of the Project Medical Officer (Joseph Kwentus)
13. Ethical Considerations (Wayne Alves)
PERSPECTIVES ON NEUROEMERGENCY DRUG DEVELOPMENT
14. Industry Perspective on Drug Development (Thomas C. Wessel, Chris Gallen)
15. Regulatory Considerations (Lisa Travis)
| Bibliographic details |
Hardbound, 360 pages, publication date: DEC-2005
ISBN-13: 978-0-12-648082-5
ISBN-10: 0-12-648082-6
Imprint: ACADEMIC PRESS
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| Price and Ordering |
Price:
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USD 190
EUR 135.95
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095/945
Last update: 30 Nov 2009
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