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Translational Medicine in CNS Drug Development

Translational Medicine in CNS Drug Development
Author: George G. Nomikos
Publisher: Academic Press
Total Pages: 458
Release: 2019-06-18
Genre: Medical
ISBN: 0128031646

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Translational Medicine in CNS Drug Development, Volume 29, is the first book of its kind to offer a comprehensive overview of the latest developments in translational medicine and biomarker techniques. With extensive coverage on all aspects of biomarkers and personalized medicine, and numerous chapters devoted to the best strategies for developing drugs that target specific disorders, this book presents an essential reference for researchers in neuroscience and pharmacology who need the most up-to-date techniques for the successful development of drugs to treat central nervous system disorders. Despite increases in the number of individuals suffering from CNS-related disorders, the development and approval of drugs for their treatment have been hampered by inefficiencies in advancing compounds from preclinical discovery to the clinic. However, in the past decades, game-changing strides have been made in our understanding of the pathophysiology of CNS disorders and the relationship of drug exposure in plasma and CNS to pharmacodynamic measures in both animals and humans. Includes comprehensive coverage of biomarker tools and the role of personalized medicine in CNS drug development Discusses strategies for drug development for a full range of CNS indications, with particular attention to neuropsychiatric and neurocognitive disorders Includes chapters written by international experts from industry and academia


Modern CNS Drug Discovery

Modern CNS Drug Discovery
Author: Rudy Schreiber
Publisher: Springer Nature
Total Pages: 285
Release: 2021-06-17
Genre: Medical
ISBN: 3030623513

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This textbook provides a comprehensive overview of the currently used concepts, approaches and technologies in the discovery and development of new treatments for the full spectrum of disorders of the central nervous system. It guides the reader through all essential steps, from finding an innovative idea, to the registration of a new drug. Divided into four sections, the book starts by presenting a broad perspective on current approaches in central nervous system (CNS) drug discovery. The second section addresses the generation of ideas for the identification of targets and novel treatment strategies; covers core functions in early discovery, and provides an example of a novel treatment paradigm: brain stimulation. The third section highlights strategies and technologies in translational CNS drug discovery. In an effort to bridge the gap between discovery and clinical development, it also covers brain imaging, EEG and cognitive testing approaches. The fourth section extensively discusses the clinical phase of drug development, covering the basics of early clinical testing for psychopharmacological drugs. The book’s final chapter addresses the registration for newly developed drugs. Written by experts from academia and industry, the book covers important basics and best practices, as well as recent developments in drug discovery. Offering in-depth insights into the world of drug development, it represents essential reading for early researchers who want to prepare for a career in drug discovery in academia or industry.


Imaging in CNS Drug Discovery and Development

Imaging in CNS Drug Discovery and Development
Author: David Borsook
Publisher: Springer Science & Business Media
Total Pages: 395
Release: 2010-03-10
Genre: Medical
ISBN: 1441901345

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Drug development today needs to balance agility, speed, and risk in defining probability of success for molecules, mechanisms, and therapeutic concepts. New techniques such as fMRI promise to be part of a sequence that could transform drug development. Although numerous review articles exist that discuss the use of imaging in drug development, no one source is available that combines the various techniques and includes a discussion of disease mapping. Imaging in CNS Drug Discovery and Development, Implications for Disease and Therapy will serve to distill the most salient developments in the use of imaging in drug development and disease mapping. It will launch evolving concepts that integrate new imaging technologies and paradigms with molecular medicine and molecular profiling ("monics") as well as consider the ethical issues that arise as a result of disease or state diagnosis and the use of imaging in the public eye.


Translational Neuroimaging

Translational Neuroimaging
Author: Robert A. McArthur
Publisher: Academic Press
Total Pages: 464
Release: 2012-10-26
Genre: Medical
ISBN: 0123869455

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This book covers methodical issues in human and animal neuroimaging translational research as well as detailed applied examples of the use of neuroimaging in neuropsychiatric disorders and the development of drugs for their treatment. Offering an accompanying website with illustrations and text available for further knowledge and presentations, Translational Neuroimaging: Tools for CNS Drug Discovery, Development and Treatment appeals to non-clinical and clinical neuroscientists working in and studying neuropsychiatric disorders and their treatment as well as providing the novice researcher or researcher outside of his/her expertise the opportunity to understand the background of translational research and the use of imaging in this field. Provides a background to translational research and the use of brain imaging in neuropsychiatric disorders.


Improving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 107
Release: 2014-02-06
Genre: Medical
ISBN: 0309292492

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Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.


Animal and Translational Models for CNS Drug Discovery: Neurological Disorders

Animal and Translational Models for CNS Drug Discovery: Neurological Disorders
Author: Robert A. McArthur
Publisher: Academic Press
Total Pages: 416
Release: 2008-11-18
Genre: Medical
ISBN: 9780080920382

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Neurological Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for neurological disorders such as neurofibromatosis, Alzheimer’s disease, Parkinson’s disease, Huntington disease, ALS, and the epilepsies. Neurological Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the second volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, which is also available for purchase individually. Clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process Critical evaluation of animal and translational models improving transition from drug discovery and clinical development Emphasis on what results mean to the overall drug discovery process Exploration of issues in clinical trial design and conductance in each therapeutic area


Animal and Translational Models for CNS Drug Discovery

Animal and Translational Models for CNS Drug Discovery
Author: Robert A. McArthur
Publisher: Academic Press
Total Pages: 1367
Release: 2008-11-27
Genre: Science
ISBN: 0080920411

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Animal and Translational Models for CNS Drug Discovery combines the experience of academic, clinical and pharmaceutical neuroscientists in a unique collaborative approach to provide a greater understanding of the relevance of animal models of neuropsychiatric disorders and their role as translational tools for the discovery of CNS drugs being developed for the treatment of these disorders. The focus of this three-volume series of essays is to present a consensual picture of the translational value of animal models from leading experts actively involved in the use of animal models for understanding fundamental neurobiology of CNS disorders and the application of this knowledge to CNS drug discovery, and clinical investigators involved in clinical trials, drug development and eventual registration of novel pharmaceuticals. Each volume of the Animal and Translational Models for CNS Drug Discovery series is dedicated to the development and use of animal models in key therapeutic areas in psychiatric, neurologic and reward deficit disorders. Each volume has introductory chapters expressing the view of the role and relevance of animal models for CNS drug discovery and development from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in relevant therapeutic areas and discusses the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. - Provides clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process - Critical evaluation of animal and translational models improving transition from drug discovery and clinical development - Emphasizes what results mean to the overall drug discovery process - Explores issues in clinical trial design and conductance in each therapeutic area - Each volume is available for purchase individually.


Translating Molecules into Medicines

Translating Molecules into Medicines
Author: Shobha N. Bhattachar
Publisher: Springer
Total Pages: 461
Release: 2017-04-21
Genre: Medical
ISBN: 3319500422

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Tackling translational medicine with a focus on the drug discovery development-interface, this book integrates approaches and tactics from multiple disciplines, rather than just the pharmaceutical aspect of the field. The authors of each chapter address the paradox between the molecular understanding of diseases, drug discovery, and drug development. Laying out the detailed trends from various fields, different chapters are dedicated to target engagement, toxicological safety assessments, and the compelling relationship of optimizing early clinical studies with design strategies. The book also highlights the importance of balancing the three pillars: sufficient efficacy, acceptable safety and appropriate pharmacokinetics, all of which are crucial to successful efforts in discovery and development. With discussions regarding the combined approaches of molecular research, personalized medicine, pre-clinical and clinical development, as well as targeted therapies—this compendium is a flexible fit, perfect for professionals in the pharmaceutical industry and related academic fields.


Animal and Translational Models for CNS Drug Discovery: Psychiatric Disorders

Animal and Translational Models for CNS Drug Discovery: Psychiatric Disorders
Author: Robert A. McArthur
Publisher: Academic Press
Total Pages: 528
Release: 2008-11-17
Genre: Medical
ISBN: 008092039X

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Psychiatric Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for psychiatric disorders such as anxiety, obsessive-compulsive disorder, depression, schizophrenia, bipolar disorder, ADHD, and autistic spectrum disorder. Psychiatric Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the first volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, and is also available for purchase individually. Provides clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process Critical evaluation of animal and translational models improving transition from drug discovery and clinical development Emphasizes what results mean to the overall drug discovery process Explores issues in clinical trial design and conductance in each therapeutic area Psychiatric Disorders is available for purchase individually.