Testing for Abuse Liability of Drugs in Humans

Testing for Abuse Liability of Drugs in Humans PDF

Author: Marian W. Fischman

Publisher:

Published: 1989

Total Pages: 420

ISBN-13:

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Representatives from industry, academia and government discuss issues related to testing for drug abuse liability and dependence potential. Contributors critically assess current methods for evaluating drugs in human subjects and describe both the advantages and limitations of each approach. This information permits identification of areas in which further research and development are needed.

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals PDF

Author: Carrie Markgraf

Publisher: Academic Press

Published: 2015-07-14

Total Pages: 320

ISBN-13: 0124202160

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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

Prediction and prevention of prescription drug abuse

Prediction and prevention of prescription drug abuse PDF

Author: Julie A. Marusich

Publisher: RTI Press

Published: 2013-07-22

Total Pages: 16

ISBN-13:

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In 2011, the prevalence of prescription drug abuse exceeded that of any other illicit drug except marijuana. Consequently, efforts to curtail abuse of new medications should begin during the drug development process, where abuse liability can be identified and addressed before a candidate medication has widespread use. The first step in this process is scheduling with the Drug Enforcement Agency so that legal access is appropriately restricted, dependent upon levels of abuse risk and medical benefit. To facilitate scheduling, the Food and Drug Administration (FDA) has published guidance for industry that describes assessment of abuse liability. The purpose of this paper is to review methods that may be used to satisfy the FDA's regulatory requirements for animal behavioral and dependence pharmacology. Methods include psychomotor activity, self-administration (an animal model of the rewarding effects of a drug), drug discrimination (an animal model of the subjective effects of a drug), and evaluation of tolerance and dependence. Data from tests with known drugs of abuse illustrate typical results. While the use of preclinical data to predict abuse liability is an imperfect process, these methods have substantial predictive validity. The ultimate goal is to increase consumer safety through appropriate scheduling of new medications.

Pathways of Addiction

Pathways of Addiction PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1996-11-01

Total Pages: 330

ISBN-13: 0309055334

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Drug abuse persists as one of the most costly and contentious problems on the nation's agenda. Pathways of Addiction meets the need for a clear and thoughtful national research agenda that will yield the greatest benefit from today's limited resources. The committee makes its recommendations within the public health framework and incorporates diverse fields of inquiry and a range of policy positions. It examines both the demand and supply aspects of drug abuse. Pathways of Addiction offers a fact-filled, highly readable examination of drug abuse issues in the United States, describing findings and outlining research needs in the areas of behavioral and neurobiological foundations of drug abuse. The book covers the epidemiology and etiology of drug abuse and discusses several of its most troubling health and social consequences, including HIV, violence, and harm to children. Pathways of Addiction looks at the efficacy of different prevention interventions and the many advances that have been made in treatment research in the past 20 years. The book also examines drug treatment in the criminal justice setting and the effectiveness of drug treatment under managed care. The committee advocates systematic study of the laws by which the nation attempts to control drug use and identifies the research questions most germane to public policy. Pathways of Addiction provides a strategic outline for wise investment of the nation's research resources in drug abuse. This comprehensive and accessible volume will have widespread relevanceâ€"to policymakers, researchers, research administrators, foundation decisionmakers, healthcare professionals, faculty and students, and concerned individuals.

Testing and Evaluation of Drugs of Abuse

Testing and Evaluation of Drugs of Abuse PDF

Author: Martin W. Adler

Publisher: Wiley

Published: 1990

Total Pages: 320

ISBN-13: 9780471567431

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This work describes how critical biological information on today's abused drugs is obtained in both laboratory and clinical settings. Recent methodological advances, both great and small, are presented in a concise manner by experienced researchers and scholars. The text covers wholesale innovations in methodology, in addition to simple modifications of existing methods that often yield great advances, and the strengths and weaknesses of all methods are assessed. The survey is comprehensive and uncovers key characteristics of abused drugs at the receptor level, on animal behavior, and in humans.