Principles of laboratory assessment of drug abuse liability and implications for clinical development

被引:159
作者
Carter, Lawrence P. [3 ]
Griffiths, Roland R. [1 ,2 ]
机构
[1] Johns Hopkins Univ, Dept Psychiat & Behav Sci, Johns Hopkins Sch Med, BPRU, Baltimore, MD 21224 USA
[2] Johns Hopkins Univ, Dept Neurosci, Johns Hopkins Sch Med, BPRU, Baltimore, MD 21224 USA
[3] Univ Arkansas Med Sci, Dept Psychiat, Inst Psychiat Res, Addict Res Ctr, Little Rock, AR 72205 USA
关键词
Abuse liability; Clinical trial; Drug abuse; Drug development; Drug discrimination; Self-administration; RELATIVE REINFORCING EFFICACY; SCHEDULE-CONTROLLED BEHAVIOR; MULTIPLE-CHOICE PROCEDURE; TREATED RHESUS-MONKEYS; DISCRIMINATIVE STIMULUS; GAMMA-HYDROXYBUTYRATE; SQUIRREL-MONKEYS; TRAMADOL HYDROCHLORIDE; RISK-MANAGEMENT; UNITED-STATES;
D O I
10.1016/j.drugalcdep.2009.04.003
中图分类号
R194 [卫生标准、卫生检查、医药管理];
学科分类号
100404 [儿少卫生与妇幼保健学];
摘要
Abuse liability testing plays an important role in informing drug development, regulatory processes, and clinical practice. This paper describes the current "gold standard" methodologies that are used for laboratory assessments of abuse liability in non-human and human subjects. Particular emphasis is given to procedures such as non-human drug discrimination, self-administration, and physical dependence testing, and human dose-effect abuse liability studies that are commonly used in regulatory submissions to governmental agencies. The potential benefits and risks associated with the inclusion of measures of abuse liability in industry-sponsored clinical trials is discussed. Lastly, it is noted that many factors contribute to patterns of drug abuse and dependence outside of the laboratory setting and positive or negative signals in abuse liability Studies do not always translate to high or low levels of actual abuse or dependence. Well-designed patient and physician education, pharmacovigilance, and postmarketing surveillance can reduce the diversion and misuse of drugs with abuse liability and can effectively foster the protection and promotion of public health. (C) 2009 Elsevier Ireland Ltd. All rights reserved.
引用
收藏
页码:S14 / S25
页数:12
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