December 3, 2020

Download Ebook Free Nonclinical Assessment Of Abuse Potential For New Pharmaceuticals

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals
Author : Carrie Markgraf,Thomas Hudzik,David Compton
Publisher : Academic Press
Release Date : 2015-07-14
Category : Medical
Total pages :320
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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

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development
Author : Ali S. Faqi
Publisher : Academic Press
Release Date : 2016-11-03
Category : Medical
Total pages :986
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A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology

Stem Cells in Toxicology and Medicine

Stem Cells in Toxicology and Medicine
Author : Saura C. Sahu
Publisher : John Wiley & Sons
Release Date : 2016-10-13
Category : Science
Total pages :560
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A comprehensive and authoritative compilation of up-to-date developments in stem cell research and its use in toxicology and medicine Presented by internationally recognized investigators in this exciting field of scientific research Provides an insight into the current trends and future directions of research in this rapidly developing new field A valuable and excellent source of authoritative and up-to-date information for researchers, toxicologists, drug industry, risk assessors and regulators in academia, industry and government

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
Author : Ali S. Faqi
Publisher : Academic Press
Release Date : 2012-10-18
Category : Medical
Total pages :1024
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A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies
Author : William J. Brock,Barbara Mounho,Lijie Fu
Publisher : John Wiley & Sons
Release Date : 2014-05-02
Category : Science
Total pages :560
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A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Technologies for Understanding and Preventing Substance Abuse and Addiction

Technologies for Understanding and Preventing Substance Abuse and Addiction
Author : DIANE Publishing Company
Publisher : DIANE Publishing
Release Date : 1996-04
Category :
Total pages :250
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Focuses on several factors that are necessary for substance abuse & addiction to occur, including an examination of the biological research regarding the phenomenon of addiction to a variety of substances. Describes individual risk & protection factors that contribute to the abuse, & addiction to alcohol & drugs. Looks at how risk & protection factors play out in subcultures & in major activity settings including the home, school, workplace & recreation settings. Addresses a range of legislative options for Congress. History of drug control policy in the U.S.

Advanced Issue Resolution in Safety Pharmacology

Advanced Issue Resolution in Safety Pharmacology
Author : Mary Jeanne Kallman,Michael Pugsley
Publisher : Academic Press
Release Date : 2018-08
Category : Medical
Total pages :592
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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

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment
Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer
Publisher : Academic Press
Release Date : 2015-03-13
Category : Medical
Total pages :716
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The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more Includes practical examples on techniques and methods to guide your daily practice Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes

Sleep Deprivation, Stimulant Medications, and Cognition

Sleep Deprivation, Stimulant Medications, and Cognition
Author : Nancy J. Wesensten
Publisher : Cambridge University Press
Release Date : 2012-08-23
Category : Medical
Total pages :129
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Sleep Deprivation, Stimulant Medications, and Cognition provides a review, synthesis and analysis of the scientific literature concerning stimulant medications and neurobehavioral performance, with an emphasis on critically evaluating the practical utility of these agents for maintaining cognitive performance and alertness in sleep-deprived (but otherwise healthy) individuals. The book explores the nature of sleep loss-induced cognitive deficits, neurophysiologic basis of these deficits, relative efficacy and limitations of various interventions (including non-pharmacological), and implications for applying these interventions in operational environments (commercial and military). Readers of this volume will gain a working knowledge of: • Mechanisms contributing to sleep loss-induced cognitive deficits • Differential effects of stimulant compounds on various aspects of cognition • Considerations (such as abuse liability) when applying stimulant interventions in operational settings • Current state and future directions for including stimulants in comprehensive fatigue-management strategies. This text is key reading for researchers and trainees in sleep and psychopharmacology.

Biological components of substance abuse and addiction.

Biological components of substance abuse and addiction.
Author : Anonim
Publisher : DIANE Publishing
Release Date : 2020
Category :
Total pages :129
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Behavioural Models in Psychopharmacology

Behavioural Models in Psychopharmacology
Author : Paul Willner
Publisher : Cambridge University Press
Release Date : 1991-02-21
Category : Medical
Total pages :540
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Behavioural models in psychopharmacology are used for different purposes. The main concern of industrial psychopharmacologists is specifically to develop new and improved drugs for the treatment of mental disorders, while basic scientists use animal models to investigate the underlying nature of such conditions. The important distinction between these different perspectives is made explicit for the first time in this book. By considering such conditions as anxiety, depression, mania and schizophrenia, feeding disorders, dementia, and drug dependence, this book provides a comprehensive and critical review of the adequacy of the behavioural procedures used by psychopharmacologists to model psychiatric disorders. Graduate students and research workers in pscyhopharmacology, from both academic and industrial spheres, as well as clinicians, will find this book of considerable interest.

Reporter

Reporter
Author : University of Michigan. Division of Research Development and Administration
Publisher : Unknown
Release Date : 1982
Category : Research
Total pages :129
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Principles of Safety Pharmacology

Principles of Safety Pharmacology
Author : Michael K. Pugsley,Michael J Curtis
Publisher : Springer
Release Date : 2015-06-19
Category : Medical
Total pages :481
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This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Testing for Abuse Liability of Drugs in Humans

Testing for Abuse Liability of Drugs in Humans
Author : Anonim
Publisher : Unknown
Release Date : 1989
Category :
Total pages :129
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Government Research Directory

Government Research Directory
Author : Anonim
Publisher : Unknown
Release Date : 2007
Category : Executive departments
Total pages :129
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