Abstract
Purpose-bred laboratory rats remain the preferred species to conduct preclinical safety assessments. The rat self-administration assay is considered the industry's gold standard to assess the relative abuse potential of all new CNS-active chemical entities. This chapter outlines the current best practices strategies used to assess the relative reinforcing properties of all new chemical entities. The assay is relatively robust. Specific preferences of the sponsor in regard to experimental contingencies can be modified between laboratories with little effects on the general conclusions drawn from the data generated. This assay is one of the most critical factors determinative of schedule control actions initiated by the FDA and DEA during new drug application process.
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