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 Development"is full of practical advice for successfully
designing and executing CNS drug trials, avoiding potential
pitfalls, and complying with government regulations
General
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