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Presents the complicated process of CNS drug development in a way that is engaging and informative for professionals and students.
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.
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
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.
The development of new CNS drugs is notoriously difficult. Drugs must reach CNS target sites for action and these sites are protected by a number of barriers, the most important being the blood –brain barrier (BBB). Many factors are therefore critical to consider for CNS drug delivery, e.g. active/passive transport across the BBB, intra-brain distribution, and central/systemic pharmacokinetics, to name a few. Neurological disease and trauma conditions add further complexity because CNS barriers, drug distribution and pharmacokinetics are dynamic and often changed by disease/trauma. Knowledge of all these factors and their interplay in different conditions is of utmost importance for proper CNS drug development and disease treatment. In recent years much information has become available for a better understanding of the many factors important for CNS drug delivery and how they interact to affect drug action. This book describes small and large drug delivery to the brain with an emphasis on the physiology of the BBB and the principles and concepts for drug delivery across the BBB and distribution within the brain. It contains methods descriptions for studying drug delivery, routes and approaches of administering drugs into the brain, the influence of disease, and drug industry perspectives. Therewith, it contributes to an in-depth understanding of the interplay between brain (patho)-physiology and drug characteristics. Furthermore, the content is designed to be both cutting-edge and educational, so that the book can be used in high-level training of academic and industry scientists with full references to original publications. ​
Playing an important role in the treatment of neurological disorders, the delivery of drugs to central nervous system (CNS), both administered directly and administered systematically for targeted action, encounters a major challenge in the form of the blood-brain barrier (BBB), which limits the access of drugs to the brain substance. In Drug Delivery to the Central Nervous System, experts in the field present essential methods used to deliver therapeutics across the BBB, both in experimental animals and in humans. In addition to those methods, several overviews of innovative methods and their applications are presented in order to give a glimpse of the future of this research. As a volume in the successful Neuromethods series, this book presents its protocols with the kind of detailed description and implementation advice that is crucial for getting optimal results. Authoritative and cutting-edge, Drug Delivery to the Central Nervous System serves as an ideal guide to scientists continuing to pursue knowledge of the delicate interactions between pharmaceuticals and the brain.
Brain Targeted Drug Delivery Systems: A Focus on Nanotechnology and Nanoparticulates provides a guide on nanoparticulates to both academic and industry researchers. The book discusses key points in the development of brain targeted drug delivery, summarizes available strategies, and considers the main problems and pitfalls evidenced in current studies on brain targeted drug delivery systems. As the brain is the most important organ in the human body, and disorders of the central nervous system (CNS) are the most serious threat to human life, this book highlights advances and new research in drug delivery methods to the brain. - Provides an overview of brain targeting drug delivery that is useful to both academic and industry-based researchers - Discusses key points in developing brain targeting drug delivery systems - Summarizes and presents currently available strategies for brain targeting drug delivery - Covers not only current studies and their strengths, but also gives insight into the pitfalls of current research
Nanotechnology Methods for Neurological Diseases and Brain Tumors: Drug Delivery across the Blood-Brain Barrier compiles the latest (and future potential) treatment strategies for brain tumors and neurological diseases, in particular Alzheimer's, Parkinson's and stroke, those that bypass the blood/brain barrier. The current understanding of brain drug delivery and access is discussed in Chapter One, with the next section focusing on the implementation of the nose-to-brain intranasal route in brain-targeted drug delivery. In addition, nanotechnology-based brain drug delivery is covered in Chapter Three. This avenue offers impressive improvement in the treatment of neurological diseases and brain tumors by using bio-engineered systems that interact with biological systems at a molecular level. In Chapter Four, emphasis is placed on the need for brain-targeted experimental models that mimic disease conditions. Final chapters discuss the very latest advances in targeted treatment strategies for neurological diseases and brain tumors.
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.
This challenging 2001 book reviews modern neurotherapeutics from the point of view of drug targeting.