Catalogue

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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.

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.

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