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Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples of when you should use these alternatives. Case histories are provided at the end of the book to show how the data generated from the animal models play a pivitol role in the submission package for a new drug. By incorporating all of this information into one book, Nonclinical Assessment of Abuse Potential for New Pharmaceuticals is your single resource for everything you need to know to understand and implement the assessment of abuse liability. Provides a consolidated overview of the complex regulatory landscape Offers best practice methodology for conducting animal studies, including selection of doses and positive control agents that will help you improve your own abuse potential studies Includes real-life examples to illustrate how nonclinical data fit into the submission strategy
This book, based on the Flowerree Mardi Gras Symposium at Tulane University, juxtaposes contemporary research and theory from several areas of animal learning -- learning theory, comparative cognition, animal models of human behavior, and functional neurology. Investigators pursuing these different routes often work in isolation of progress being made in, what should be, related fields. This book will acquaint students and researchers with a variety of topics, ordinarily treated separately, in a way that will stimulate integrative thinking. Cognitive interpretations of animal learning are included, as well as recent developments in conditioning theory, physiological bases of learning, animal models of human behavior problems, and psychopharmacology.
Central nervous system trauma, which encompasses stroke, subarachnoid hemorrhage, head injury, and spinal cord injury, is a leading cause of death in developed countries. In the search for underlying mechanisms, membrane involvement has been the common link. This fourth volume in the Membrane-Linked Diseases series is therefore dedicated to research on CNS trauma. Focusing on the mechanism of membrane damage, Central Nervous System Trauma: Research Techniques presents a variety of experimental techniques to study the mechanism of CNS trauma. Animal and tissue culture models provide the bulk of the research findings in this area. Possible pharmacological interventions are analyzed. This volume offers numerous illustrative examples, including full color figures. This book serves as a valuable resource for students and researchers, assisting in the comprehension of current trends in CNS trauma and helping to stimulate the discovery of new research areas.
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Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues. - Focuses on pharmacology issues that result during drug development and provides de-risking techniques and practical advice - Covers a broad selection of topics, including specialized animal models, PBPK modeling, the use of high frequency EEG in problem-solving, drug-induced self-injury, abuse potential liability, biomarkers, imaging, and much more - Focuses on the resolution of these issues in order to better address regulatory expectancies and develop safer, more effective drugs
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