Purpose: To award Task Order 75N95020F00002 (GLP Interaction Safety Studies in Rats and Dogs) under IDIQ No. HHSN271201800019I.

根据工作说明书（SOW）任务1，承包商应在啮齿动物中进行急性药物相互作用研究。这些研究中使用的具体方法应获得承包商代表（COR）的批准。根据工作说明书任务19，承包商应进行， 在COR的指导下，进行特殊的体内或体外毒理学或药代动力学研究，其细节无法在授予合同之前指定。示例包括任务1至18（含）中指定方案的修改，以允许对供试品进行更专业的评价，并制定具有类似临床情况特征的方案。这些研究的目的是确定供试品与可卡因或甲基苯丙胺、阿片类药物或乙醇联合使用的安全性。仅出于成本估计的目的，假设COR指定的供试品将通过经口灌胃给药，并与可卡因或甲基苯丙胺（相互作用品）联合试验，通过静脉（尾静脉）注射给药，并且研究将分两个阶段进行。供试品和相互作用品之间的间隔为2小时。应评估对致死率、行为（包括惊厥）和临床观察结果的影响。在本研究中，将有12个处理组，每组由10只雄性大鼠组成。在给药日每隔4小时观察动物的给药效果，此后3天每天观察一次。给药后约4天人道处死动物。应测定所有供试品和相互作用品给药溶液，以验证同一性和浓度。NIDA需要一份完整的研究报告。应按照药物非临床研究质量管理规范（GLP）指南（CFR第21篇第58部分）进行研究并报告。

Under Statement of Work (SOW) Task 1, the Contractor shall conduct acute drug interaction studies in rodents. Specific methods to be used in these studies shall be subject to the approval of the Contracting Officer’s Representative (COR). Under SOW Task 19, the Contractor shall conduct, as directed by the COR, special in vivo or in vitro toxicology or pharmacokinetic studies, the details of which cannot be specified in advance of the contract award. Examples include modifications of the specified protocols in Tasks 1 to 18, inclusive, to allow for a more specialized evaluation of test articlesand development of a protocol with features similar to a clinical situation. The objective of these studies shall be to determine the safety of a test article in combination with cocaine or methamphetamine, an opiate or ethanol. For purposes of cost estimation only, assume that a test article to be designated by the COR will be administered by oral gavage and tested in combination with cocaine or methamphetamine (interaction article), administered by intravenous (tail vein) injection, and that the study will be conducted in two sessions. The interval between the test article and interaction article will be 2 hours. Effects on lethality, behavior (to include convulsions) and clinical observations shall be assessed. In this study there would be 12 treatment groups comprised of 10 male rats each. Animals would be observed for treatment effects at intervals for as many as 4 hours on the dosing day and once daily for 3 days thereafter. The animals would be humanely sacrificed approximately 4 days after dosing. All test article and interaction article dosing solutions shall be assayed to verify identity and concentration. NIDA requires a complete report for the study. The study shall be conducted and reported in conformance with Good Laboratory Practice (GLP) guidelines (CFR Title 21 Part 58).