Prediction and prevention of prescription drug abuse: Role of preclinical assessment of substance abuse liability
Julie A. Marusich · Timothy W. Lefever · Scott P. Novak · Bruce E. Blough · Jenny L. Wiley
Jul 2013 · RTI Press
Ebook
16
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About this ebook
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.
About the author
PhD, is a neurobehavioral pharmacologist in the Pharmacology group at RTI International.
MA, is a laboratory manager in RTI’s Pharmacology group.
PhD, is a senior developmental epidemiologist in RTI’s Behavioral Health Epidemiology program.
PhD, is a senior research chemist in RTI’s Organic and Medicinal Chemistry group.
PhD, is a senior behavioral pharmacologist in RTI’s Pharmacology group.
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