Julie A Marusich, Timothy W Lefever, Scott P Novak, Bruce E Blough, Jenny L Wiley
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引用次数: 0
摘要
2011 年,处方药滥用的流行率超过了除大麻以外的任何其他非法药物。因此,遏制新药滥用的工作应从药物开发过程中开始,这样可以在候选药物广泛使用之前发现并解决滥用问题。这一过程的第一步是与缉毒机构进行排期,以便根据滥用风险和医疗益处的程度适当限制合法使用。为便于安排,美国食品和药物管理局(FDA)发布了行业指南,介绍了滥用责任评估。本文旨在介绍可用于满足 FDA 对动物行为和依赖性药理学监管要求的方法。这些方法包括精神运动活动、自我给药(药物奖励效应的动物模型)、药物辨别(药物主观效应的动物模型)以及耐受性和依赖性评估。RTI 使用已知滥用药物进行的测试数据说明了典型的测试结果,并证明 RTI 能够进行这些测试。虽然使用临床前数据来预测滥用责任是一个不完美的过程,但它具有很大的预测效力。最终目标是通过适当安排新药的使用时间来提高消费者的安全。
Prediction and Prevention of Prescription Drug Abuse: Role of Preclinical Assessment of Substance Abuse Liability.
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 conducted at RTI with known drugs of abuse illustrate typical results, and demonstrate that RTI is capable of performing these tests. While using preclinical data to predict abuse liability is an imperfect process, it has substantial predictive validity. The ultimate goal is to increase consumer safety through appropriate scheduling of new medications.