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Critical Pathways To Success In Cns Drug Development
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Book Synopsis Critical Pathways to Success in CNS Drug Development by : Neal R. Cutler
Download or read book Critical Pathways to Success in CNS Drug Development written by Neal R. Cutler and published by John Wiley & Sons. This book was released on 2010-01-22 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering the latest advances in CNS drug development, this bookwill guide all those involved in pre-clinical to early clinicaltrials. The authors describe how recent innovations can acceleratethe development of novel CNS compounds, improve early detection ofefficacy and toxicity signals, and increase the safety oflater-stage clinical trials. The current crisis in the drug development industry iscritically reviewed, as well as the steps needed to correct theproblems, including new government-backed regulations andindustry-based innovations designed to accelerate CNS drugdevelopment in the future. Animal-based models of major CNS disorders are described indetail, and the ability of the latest in vitro and computer-basedmodels to simulate CNS disease states and predict drug efficacy andside-effects are examined. Particular attention is given tothe growing use of biomarkers and how they can be used effectivelyin early human trials as signals of potential drug efficacy, aswell as the increasingly important role of imaging studies to guidedose selection. Cognitive assessments that can be useful indicatorsof effect in patient populations are also discussed. Written by a team of clinical scientists involved in CNS drugtrials for over 20 years, and based on a wealth of drug developmentand clinical trial experience, Critical Pathways to Success inCNS Drug Developmentis full of practical advice forsuccessfully designing and executing CNS drug trials, avoidingpotential pitfalls, and complying with government regulations
Book Synopsis Principles of CNS Drug Development by : John Kelly
Download or read book Principles of CNS Drug Development written by John Kelly and published by John Wiley & Sons. This book was released on 2009-10-27 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title acts as a primer, giving students and newcomers to the field an opportunity to learn about the breadth of the CNS drug discovery. The book outlines the core processes in drug discovery and development for CNS disorders, from evaluating drugs for desirable efficacy, safety and pharmacokinetic features in preclinical (using in vitro and in vivo models) and clinical experimentation to identifying future drug targets. Containing up-to-date experimental evidence and detailing the main impediments in the pipeline of CNS drug discovery and development, this is a key reference for those involved in all stages of CNS drug discovery. Key Features: Discusses in detail the key stages of CNS drug discovery, outlining the particular requirements and obstacles for CNS drugs Addresses safety concerns and future drug targets Provides succinct background information about the major CNS diseases Examples of specific drugs are used throughout to describe the development of a new drug from conception to clinical use and post-market surveillance Primary reasons for drug failure are given for each stage
Book Synopsis Animal and Translational Models for CNS Drug Discovery: Neurological Disorders by : Robert A. McArthur
Download or read book Animal and Translational Models for CNS Drug Discovery: Neurological Disorders written by Robert A. McArthur and published by Academic Press. This book was released on 2008-11-18 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Early Drug Development by : Mitchell N. Cayen
Download or read book Early Drug Development written by Mitchell N. Cayen and published by John Wiley & Sons. This book was released on 2011-02-25 with total page 507 pages. Available in PDF, EPUB and Kindle. Book excerpt: The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.
Book Synopsis Inflammatory and Autoimmune Disorders of the Nervous System in Children by : Russell C. Dale
Download or read book Inflammatory and Autoimmune Disorders of the Nervous System in Children written by Russell C. Dale and published by John Wiley & Sons. This book was released on 2010-01-19 with total page 521 pages. Available in PDF, EPUB and Kindle. Book excerpt: Inflammatory disorders of the nervous system, although individually uncommon, collectively make up 10-20% of acute paediatric neurology presentations and many are potentially treatable. Research into them is lagging behind adult research, but better diagnosis and often simple treatments could lead to substantial clinical benefit and reduction in long-term disability. This book provides a detailed and comprehensive summary of the childhood diseases that are, or are likely to be, caused by the immune system. The authors not only describe these disorders and their treatments comprehensively, helping pediatricians and pediatric neurologists to improve their understanding and recognition of the conditions, but also highlight recent and exciting developments that will be of considerable importance in the future.
Book Synopsis Neuronal Networks in Brain Function, CNS Disorders, and Therapeutics by : Carl Faingold
Download or read book Neuronal Networks in Brain Function, CNS Disorders, and Therapeutics written by Carl Faingold and published by Academic Press. This book was released on 2013-12-26 with total page 537 pages. Available in PDF, EPUB and Kindle. Book excerpt: Neuronal Networks in Brain Function, CNS Disorders, and Therapeutics, edited by two leaders in the field, offers a current and complete review of what we know about neural networks. How the brain accomplishes many of its more complex tasks can only be understood via study of neuronal network control and network interactions. Large networks can undergo major functional changes, resulting in substantially different brain function and affecting everything from learning to the potential for epilepsy. With chapters authored by experts in each topic, this book advances the understanding of: How the brain carries out important tasks via networks How these networks interact in normal brain function Major mechanisms that control network function The interaction of the normal networks to produce more complex behaviors How brain disorders can result from abnormal interactions How therapy of disorders can be advanced through this network approach This book will benefit neuroscience researchers and graduate students with an interest in networks, as well as clinicians in neuroscience, pharmacology, and psychiatry dealing with neurobiological disorders. Utilizes perspectives and tools from various neuroscience subdisciplines (cellular, systems, physiologic), making the volume broadly relevant Chapters explore normal network function and control mechanisms, with an eye to improving therapies for brain disorders Reflects predominant disciplinary shift from an anatomical to a functional perspective of the brain Edited work with chapters authored by leaders in the field around the globe – the broadest, most expert coverage available
Book Synopsis Translational Neuroimaging by : Robert A. McArthur
Download or read book Translational Neuroimaging written by Robert A. McArthur and published by Academic Press. This book was released on 2012-10-05 with total page 463 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Neuroimaging: Tools for CNS Drug Discovery, Development and Treatment combines the experience of academic, clinical and industrial neuroimagers in a unique collaborative approach to provide an integrated perspective of the use of small animal and human brain imaging in developing and validating translational models and biomarkers for the study and treatment of neuropsychiatric disorders. Translational Neuroimaging: Tools for CNS Drug Discovery, Development and Treatment examines the translational role of neuroimaging in model development from preclinical animal models, to human experimental medicine, and finally to clinical studies. The focus of this book 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 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. 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 Critical discussion of the potential and limitations of neuroimaging as a translational tool for identifying and validating biomarkers Identifies cross species neurosystems and common endpoints necessary to help accelerate CNS drug discovery and development for the treatment of neuropsychiatric disorders
Book Synopsis Drug Repurposing by : Farid A. Badria
Download or read book Drug Repurposing written by Farid A. Badria and published by BoD – Books on Demand. This book was released on 2020-12-02 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug repurposing or drug repositioning is a new approach to presenting new indications for common commercial and clinically approved existing drugs. For example, chloroquine, an old antimalarial drug, showed promising results for treating COVID-19, interfering with MDR in several types of cancer, and chemosensitizing human leukemic cells.This book focuses on the hypothesis, risk/benefits, and economic impacts of drug repurposing on drug discovery in dermatology, infectious diseases, neurological disorders, cancer, and orphan diseases. It brings together up-to-date research to provide readers with an informative, illustrative, and easy-to-read book useful for students, clinicians, and the pharmaceutical industry.
Book Synopsis Translational Medicine in CNS Drug Development by : George G. Nomikos
Download or read book Translational Medicine in CNS Drug Development written by George G. Nomikos and published by Academic Press. This book was released on 2019-06-18 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Sociological Reflections on the Neurosciences by : Martyn Pickersgill
Download or read book Sociological Reflections on the Neurosciences written by Martyn Pickersgill and published by Emerald Group Publishing. This book was released on 2012-07-30 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: The neurosciences are more than a collection of scientific practices - they offer up various ways of thinking about mind, body and society. This title casts light on the place, role and impact of neuroscience. It reflects on the insights the neurosciences have to offer sociology.
Book Synopsis Handbook of Innovations in Central Nervous System Regenerative Medicine by : António Salgado
Download or read book Handbook of Innovations in Central Nervous System Regenerative Medicine written by António Salgado and published by Elsevier. This book was released on 2020-06-10 with total page 712 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Innovations in CNS Regenerative Medicine provides a comprehensive overview of the CNS regenerative medicine field. The book describes the basic biology and anatomy of the CNS and how injury and disease affect its balance and the limitations of the present therapies used in the clinics. It also introduces recent trends in different fields of CNS regenerative medicine, including cell transplantation, bio and neuro-engineering, molecular/pharmacotherapy therapies and enabling technologies. Finally, the book presents successful cases of translation of basic research to first-in-human trials and the steps needed to follow this path. Areas such as cell transplantation approaches, bio and neuro-engineering, molecular/pharmacotherapy therapies and enabling technologies are key in regenerative medicine are covered in the book, along with regulatory and ethical issues. Describes the basic biology and anatomy of the CNS and how injury and disease affect its balance Discusses the limitations of present therapies used in the clinics Introduces the recent trends in different fields of CNS regenerative medicine, including cell transplantation, bio and neuro-engineering, molecular/pharmacotherapy therapies, and enabling technologies Presents successful cases of translation of basic research to first-in-human trials, along with the steps needed to follow this path
Book Synopsis Chemotherapy in Psychiatry by : Ross J. Baldessarini
Download or read book Chemotherapy in Psychiatry written by Ross J. Baldessarini and published by Springer Science & Business Media. This book was released on 2012-09-28 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: Use of psychotropic drugs has come to dominate clinical practice in psychiatry worldwide—perhaps owing largely to perceived simplicity, ease of use, and apparent efficiency, as well as apparent cost-effectiveness of such treatments. Nevertheless, medicinal treatments for patients with psychiatric disorders are but one component of comprehensive clinical care of complex human problems. Extensively updated since its second edition in 1985, Chemotherapy in Psychiatry, Third Edition, again addresses basic aspects of modern psychopharmacology and clinical applications of drugs used in the treatment of major psychiatric disorders, with major emphasis on psychotic, bipolar, and depressive disorders. The presentation covers descriptions of the main classes of psychotropic drugs, selected information concerning their known action mechanisms and metabolic disposition, and their clinical applications for acute illnesses and to prevent recurrences and long-term morbidity. Also covered are limitations and adverse effects of each type of agent, with emphasis on the fact that all psychotropic medicines have adverse effects that range from annoying to potentially lethal. Chemotherapy in Psychiatry, Third Edition, outlines the need to balance benefits and risks at the level of individual persons. Authoritative, and an important contribution to the literature, Chemotherapy in Psychiatry, Third Edition is an invaluable resource for physicians, scientists, trainees, and policymakers.
Book Synopsis The Migraine Brain by : David Borsook
Download or read book The Migraine Brain written by David Borsook and published by Oxford University Press, USA. This book was released on 2012-07-26 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Migraine Brain provides a general overview of the history of migraine, its pathophysiology, as well as in-depth details on the Clinical Perspectives and the different imaging techniques in use (MR, fMRI, DTI, VBM, PET, fMRI, and MEG). It also includes details on modulation of the brain using such techniques as TMS. The book concludes with a discussion of future uses of imaging in the diagnosis and treatment of migraines and other headaches.
Download or read book Mad Science written by Stuart A. Kirk and published by Transaction Publishers. This book was released on 2013-04-12 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: *Winner of an honorable mention from theSociety for Social Work and ResearchforOutstanding Social Work Book Award Mad Science argues that the fundamental claims of modern American psychiatry are based on misconceived, flawed, and distorted science. The authors address multiple paradoxes in American mental health research, including the remaking of coercion into scientific psychiatric treatment, the adoption of an unscientific diagnostic system that controls the distribution of services, and how drug treatments have failed to improve the mental health outcome. When it comes to understanding and treating mental illness, distortions of research are not rare, misinterpretation of data is not isolated, and bogus claims of success are not voiced by isolated researchers seeking aggrandizement. This book’s detailed analysis of coercion and community treatment, diagnosis, and psychopharmacology reveals that these characteristics are endemic, institutional, and protected in psychiatry. They are not just bad science, but mad science. This book provides an engaging and readable scientific and social critique of current mental health practices. The authors are scholars, researchers, and clinicians who have written extensively about community care, diagnosis, and psychoactive drugs. This paperback edition makes Mad Science accessible to all specialists in the field as well as to the informed public.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309495849 Total Pages :93 pages Book Rating :4.3/5 (94 download)
Book Synopsis Advancing Gene-Targeted Therapies for Central Nervous System Disorders by : National Academies of Sciences, Engineering, and Medicine
Download or read book Advancing Gene-Targeted Therapies for Central Nervous System Disorders written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-12-01 with total page 93 pages. Available in PDF, EPUB and Kindle. Book excerpt: On April 23 and 24, 2019 the Forum on Neuroscience and Nervous System Disorders convened a workshop titled "Advancing Gene-Targeted Therapies for Central Nervous System Disorders" in Washington, DC. This public workshop brought together experts and key stakeholders from academia, government, industry, philanthropic foundations, and disease/patient-focused nonprofit organizations to explore approaches for advancing the development of gene-targeted therapies for central nervous system (CNS) disorders, and implications of developing these therapies. Participants explored lessons learned from both successful and unsuccessful clinical development programs; new knowledge about the genetic underpinnings of brain disorders; the current status and future potential of gene-targeted therapies for CNS disorders; challenges and potential solutions for translating preclinical findings to approved therapies; and patient and caregiver perspectives. They also discussed what will be needed to develop these therapies for common disorders such as Alzheimer's and Parkinson's disease, as well as neuropsychiatric and neurodevelopmental disorders such as schizophrenia and autism. The workshop included approaches that target both DNA and RNA, as well as gene products using viral vectors, antisense oligonucleotides, and RNA interference. This publication summarizes the presentations and discussion of the workshop.
Book Synopsis Drug Discovery and Evaluation: Methods in Clinical Pharmacology by : H.Gerhard Vogel
Download or read book Drug Discovery and Evaluation: Methods in Clinical Pharmacology written by H.Gerhard Vogel and published by Springer Science & Business Media. This book was released on 2010-12-15 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
