Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

Author: H. Gerhard Vogel

Publisher: Springer

Published: 2013-02-27

Total Pages: 0

ISBN-13: 9783642252396

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-A landmark in the continuously changing world of drugs -Essential reading for scientists and managers in the pharmaceutical industry involved in drug finding, drug development and decision making in the development process -Of use for government institutions and committees working on official guidelines for drug evaluation worldwide


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

Published: 2014-02-06

Total Pages: 107

ISBN-13: 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.


Neurological Disorders

Neurological Disorders

Author: World Health Organization

Publisher: World Health Organization

Published: 2006

Total Pages: 233

ISBN-13: 9241563362

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Although there are several gaps in understanding the many issues related to neurological disorders, we know enough to be able to shape effective policy responses to some of the most common. This book describes and discusses the increasing public health impact of common neurological disorders such as dementia, epilepsy, headache disorders, multiple sclerosis, neuroinfections, neurological disorders associated with malnutrition, pain associated with neurological disorders, Parkinson's disease, stroke and traumatic brain injuries. It provides information and advice on public health interventions that may reduce their occurrence and consequences, and offers health professionals and planners the opportunity to assess the burden caused by these disorders. The clear message that emerges is that unless immediate action is taken globally, the neurological burden is likely to become an increasingly serious and unmanageable.


Caffeine for the Sustainment of Mental Task Performance

Caffeine for the Sustainment of Mental Task Performance

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2002-01-07

Total Pages: 172

ISBN-13: 0309082587

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This report from the Committee on Military Nutrition Research reviews the history of caffeine usage, the metabolism of caffeine, and its physiological effects. The effects of caffeine on physical performance, cognitive function and alertness, and alleviation of sleep deprivation impairments are discussed in light of recent scientific literature. The impact of caffeine consumption on various aspects of health, including cardiovascular disease, reproduction, bone mineral density, and fluid homeostasis are reviewed. The behavioral effects of caffeine are also discussed, including the effect of caffeine on reaction to stress, withdrawal effects, and detrimental effects of high intakes. The amounts of caffeine found to enhance vigilance and reaction time consistently are reviewed and recommendations are made with respect to amounts of caffeine appropriate for maintaining alertness of military personnel during field operations. Recommendations are also provided on the need for appropriate labeling of caffeine-containing supplements, and education of military personnel on the use of these supplements. A brief review of some alternatives to caffeine is also provided.


Basic Concepts in Pharmacology: What You Need to Know for Each Drug Class, Fourth Edition

Basic Concepts in Pharmacology: What You Need to Know for Each Drug Class, Fourth Edition

Author: Janet L. Stringer

Publisher: McGraw Hill Professional

Published: 2011-03-11

Total Pages: 254

ISBN-13: 0071769420

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A time-saving, stress-reducing approach to learning the essential concepts of pharmacology Great for USMLE review! "This could be a very useful tool for students who struggle with understanding the most basic concepts in pharmacology for course and licensure examinations. 3 Stars."--Doody's Review Service Basic Concepts in Pharmacology provides you with a complete framework for studying -– and understanding -- the fundamental principles of drug actions. With this unique learning system, you’ll be able to identify must-know material, recognize your strengths and weaknesses, minimize memorization, streamline your study, and build your confidence. Basic Concepts in Pharmacology presents drugs by class, details exactly what you need to know about each class, and reinforces key concepts and definitions. With this innovative text you’ll be able to: Recognize the concepts you truly must know before moving on to other material Understand the fundamental principles of drug actions Organize and condense the drug information you must remember Review key information, which is presented in boxes, illustrations, and tables Identify the most important drugs in each drug class Seven sections specifically designed to simplify the learning process and help you gain an understanding of the most important concepts: General Principles Drugs That Affect the Autonomic Nervous System Drugs That Affect the Cardiovascular System Drugs That Act on the Central Nervous System Chemotherapeutic Agents Drugs That Affect the Endocrine System Miscellaneous Drugs (Includes Toxicology and Poisoning)


Improving the Utility and Translation of Animal Models for Nervous System Disorders

Improving the Utility and Translation of Animal Models for Nervous System Disorders

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2013-04-25

Total Pages: 111

ISBN-13: 0309266335

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Nervous system diseases and disorders are highly prevalent and substantially contribute to the overall disease burden. Despite significant information provided by the use of animal models in the understanding of the biology of nervous system disorders and the development of therapeutics; limitations have also been identified. Treatment options that are high in efficacy and low in side effects are still lacking for many diseases and, in some cases are nonexistent. A particular problem in drug development is the high rate of attrition in Phase II and III clinical trials. Why do many therapeutics show promise in preclinical animal models but then fail to elicit predicted effects when tested in humans? On March 28 and 29, 2012, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened the workshop "Improving Translation of Animal Models for Nervous System Disorders" to discuss potential opportunities for maximizing the translation of new therapies from animal models to clinical practice. The primary focus of the workshop was to examine mechanisms for increasing the efficiency of translational neuroscience research through discussions about how and when to use animal models most effectively and then best approaches for the interpretation of the data collected. Specifically, the workshop objectives were to: discuss key issues that contribute to poor translation of animal models in nervous system disorders, examine case studies that highlight successes and failures in the development and application of animal models, consider strategies to increase the scientific rigor of preclinical efficacy testing, explore the benefits and challenges to developing standardized animal and behavioral models. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary also identifies methods to facilitate development of corresponding animal and clinical endpoints, indentifies methods that would maximize bidirectional translation between basic and clinical research and determines the next steps that will be critical for improvement of the development and testing of animal models of disorders of the nervous system.


Clinical Neurophysiology

Clinical Neurophysiology

Author: Jasper R. Daube

Publisher: Oxford University Press

Published: 2009-05-22

Total Pages: 915

ISBN-13: 0199725144

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Clinical Neurophysiology, Third Edition will continue the tradition of the previous two volumes by providing a didactic, yet accessible, presentation of electrophysiology in three sections that is of use to both the clinician and the researcher. The first section describes the analysis of electrophysiological waveforms. Section two describes the various methods and techniques of electrophysiological testing. The third section, although short in appearance, has recommendations of symptom complexes and disease entities using electroencephalography, evoked potentials, and nerve conduction studies.


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

Published: 2008-11-18

Total Pages: 413

ISBN-13: 0080920381

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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


Sites of Drug Action in the Human Brain

Sites of Drug Action in the Human Brain

Author: Anat Biegon

Publisher: CRC Press

Published: 1995-02-24

Total Pages: 202

ISBN-13: 9780849376535

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Sites of Drug Action in the Human Brain uses the results of recent analyses of the regional brain distribution and binding pattern of drugs in the human brain. This new book specifically addresses drugs of abuse and treats the effects of various drugs on behavior and mood, as well as on metabolism and blood flow in the human brain. It also presents the methodological aspects of investigating the sites of drug action in the human brain. Because it focuses on the living human brain, this book differs from other books on the subject, which primarily use the results of postmortem studies. Sites of Drug Action in the Human Brain therefore provides valuable information on the clinical aspects of drug intoxification, addiction, and toxicity.