Critical Pathways To Success In Cns Drug Development
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Critical Pathways To Success In Cns Drug Development
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Author : Neal R. Cutler
language : en
Publisher: John Wiley & Sons
Release Date : 2010-01-22
Critical Pathways To Success In Cns Drug Development written by Neal R. Cutler and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-01-22 with Medical categories.
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
Principles Of Cns Drug Development
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Author : John Kelly
language : en
Publisher: John Wiley & Sons
Release Date : 2009-10-27
Principles Of Cns Drug Development written by John Kelly and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-10-27 with Medical categories.
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
Blood Brain Barrier In Drug Discovery
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Author : Li Di
language : en
Publisher: John Wiley & Sons
Release Date : 2015-02-02
Blood Brain Barrier In Drug Discovery written by Li Di and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-02-02 with Medical categories.
Focused on central nervous system (CNS) drug discovery efforts, this book educates drug researchers about the blood-brain barrier (BBB) so they can affect important improvements in one of the most significant – and most challenging – areas of drug discovery. • Written by world experts to provide practical solutions to increase brain penetration or minimize CNS side-effects • Reviews state-of-the-art in silico, in vitro, and in vivo tools to assess brain penetration and advanced CNS drug delivery strategies • Covers BBB physiology, medicinal chemistry design principles, free drug hypothesis for the BBB, and transport mechanisms including passive diffusion, uptake/efflux transporters, and receptor-mediated processes • Highlights the advances in modelling BBB pharmacokinetics and dynamics relationships (PK/PD) and physiologically-based pharmacokinetics (PBPK) • Discusses case studies of successful CNS and non-CNS drugs, lessons learned and paths to the market
Translational Medicine In Cns Drug Development
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Author : George G. Nomikos
language : en
Publisher: Academic Press
Release Date : 2019-06-18
Translational Medicine In Cns Drug Development written by George G. Nomikos and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-18 with Medical categories.
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
Animal And Translational Models For Cns Drug Discovery Neurological Disorders
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Author : Robert A. McArthur
language : en
Publisher: Academic Press
Release Date : 2008-11-18
Animal And Translational Models For Cns Drug Discovery Neurological Disorders written by Robert A. McArthur and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-11-18 with Medical categories.
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
Improving And Accelerating Therapeutic Development For Nervous System Disorders
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2014-02-06
Improving And Accelerating Therapeutic Development For Nervous System Disorders written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-02-06 with Medical categories.
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.
Essential Cns Drug Development
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Author :
language : en
Publisher:
Release Date : 2012
Essential Cns Drug Development written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012 with Central nervous system stimulants categories.
"Central Nervous System disorders have an enormous impact on individuals and on society as a whole. The development of better treatments is crucial and is a major focus of pharmaceutical and biotechnology companies. This book explains the complicated process of CNS drug development in a way that is engaging for any interested professional or student. Chapters cover each stage of drug development, from pre-clinical research through all phases of clinical trials, to reporting to the regulatory authorities. Other key issues covered include strategic considerations, regulatory constraints, dissemination of results and ethical considerations. The user-friendly format and style enable readers to find important information quickly and easily. Written and edited by experts from different sectors actively engaged in CNS drug development, this is a unique resource for drug developers, investigators, academics and clinicians"--Provided by publisher.
Animal And Translational Models For Cns Drug Discovery 3 Vols Set
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Author : Robert A. McArthur
language : en
Publisher:
Release Date : 2008-12
Animal And Translational Models For Cns Drug Discovery 3 Vols Set written by Robert A. McArthur and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-12 with Medical categories.
Imaging In Cns Drug Discovery And Development
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Author :
language : en
Publisher:
Release Date : 2011-07-11
Imaging In Cns Drug Discovery And Development written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-07-11 with categories.
Drug Discovery And Evaluation Methods In Clinical Pharmacology
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Author : H.Gerhard Vogel
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-12-15
Drug Discovery And Evaluation Methods In Clinical Pharmacology written by H.Gerhard Vogel and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-15 with Medical categories.
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".