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Covering the latest advances in CNS drug development, this book
will guide all those involved in pre-clinical to early clinical
trials. The authors describe how recent innovations can accelerate
the development of novel CNS compounds, improve early detection of
efficacy and toxicity signals, and increase the safety of
later-stage clinical trials.
The current crisis in the drug development industry is
critically reviewed, as well as the steps needed to correct the
problems, including new government-backed regulations and
industry-based innovations designed to accelerate CNS drug
development in the future.
Animal-based models of major CNS disorders are described in
detail, and the ability of the latest in vitro and computer-based
models to simulate CNS disease states and predict drug efficacy and
side-effects are examined. Particular attention is given to
the growing use of biomarkers and how they can be used effectively
in early human trials as signals of potential drug efficacy, as
well as the increasingly important role of imaging studies to guide
dose selection. Cognitive assessments that can be useful indicators
of effect in patient populations are also discussed.
Written by a team of clinical scientists involved in CNS drug
trials for over 20 years, and based on a wealth of drug development
and clinical trial experience, Critical Pathways to Success in
CNS Drug Developmentis full of practical advice for
successfully designing and executing CNS drug trials, avoiding
potential pitfalls, and complying with government regulations
will guide all those involved in pre-clinical to early clinical
trials. The authors describe how recent innovations can accelerate
the development of novel CNS compounds, improve early detection of
efficacy and toxicity signals, and increase the safety of
later-stage clinical trials.
The current crisis in the drug development industry is
critically reviewed, as well as the steps needed to correct the
problems, including new government-backed regulations and
industry-based innovations designed to accelerate CNS drug
development in the future.
Animal-based models of major CNS disorders are described in
detail, and the ability of the latest in vitro and computer-based
models to simulate CNS disease states and predict drug efficacy and
side-effects are examined. Particular attention is given to
the growing use of biomarkers and how they can be used effectively
in early human trials as signals of potential drug efficacy, as
well as the increasingly important role of imaging studies to guide
dose selection. Cognitive assessments that can be useful indicators
of effect in patient populations are also discussed.
Written by a team of clinical scientists involved in CNS drug
trials for over 20 years, and based on a wealth of drug development
and clinical trial experience, Critical Pathways to Success in
CNS Drug Developmentis full of practical advice for
successfully designing and executing CNS drug trials, avoiding
potential pitfalls, and complying with government regulations
€122.99
Cuprins
Acknowledgements.Foreword.
1 The Impending Crisis in CNS Drug Development.
2 Animal Models and Procedures for CNS Disorders.
3 Pre-Clinical Antecedents to Early Human Clinical Trials.
4 Biomarkers and Surrogate Markers in Drug Development.
5 Neuroimaging and Cognitive Assessments in Early Drug
Development.
6 Bridging and CSF Studies.
7 A Case Study from Pre-Clinical to Early Clinical Trials.
Index.
Despre autor
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
Limba Engleză ● Format PDF ● Pagini 272 ● ISBN 9781444318586 ● Mărime fișier 1.9 MB ● Editura John Wiley & Sons ● Publicat 2010 ● Ediție 1 ● Descărcabil 24 luni ● Valută EUR ● ID 2388969 ● Protecție împotriva copiilor Adobe DRM
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