Series Introduction
监管机构要求任何药物(父or major metabolite) that penetrates the brain and has CNS activity, regardless of its therapeutic indication, be assessed for that drug’s abuse potential. In this series on Assessing Potential Drug Abuse, we are sharing how the team at Covance designs and setup accurate and valid nonclinical GLP abuse liability assessment study types required by regulatory agencies: self-administration, drug discrimination and physical dependency studies. For the first in this series, we will explore how to design and develop a comprehensive self-administration study to test for a drug’s potential abusive or addictive nature.
About the Self-Administration Study – Evaluation of the Reinforcing Effects of Test Drugs
自我管理研究评估了药物的潜力，以阳性增强效应保持杠杆压力行为。根据这一点2017 FDA行业评估指导, “if animals actively work at a behavioral task to receive a dose of the drug, it is likely that the drug will [also] be rewarding in humans.”
自我管理药物滥用责任研究的研究阶段
使用Covance示例和内部数据，本文探讨了在设计和实施有效的滥用责任研究时探讨了以下阶段，以满足监管机构要求：
- 培训 - 药物/自我管理阶段：培训研究模型以按杠杆培训，以便在适用于培训药物的固定比率（FR）的固定比率（FR）的固定比例（FR）时间表中灌注训练药物（奖励）。
- 盐灭绝阶段: in which the training drug is replaced with saline to extinguish the lever pressing behavior.
- Test drug substitution phase：在哪种盐水被替换为试验药物重新列出，并在用于训练和消光阶段的增强时间表下评估杠杆压迫行为。
- Progressive ratio (PR) schedule of reinforcement: will be conducted whenever assessment of the reinforcing efficacy of the test drug is deemed necessary to compliment the results obtained under a FR schedule.
Self-administration Data
This article will also share in-house data on self-administration studies completed related to drugs like ketamine, heroin and amphetamine.
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