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身上进行急性药物相互作用研究。在这些研究中使用的具体方法应得到签约官员代表的批准。根据SOW任务19，承包商应按照 由COR指导的，特别的体内或体外毒理学或药代动力学研究，其细节不能在合同授予之前指定。例如，修改任务1至任务18中规定的方案，以便对检测项目进行更专门的评估，并制定具有类似临床情况特征的方案。这些研究的目的应是确定测试物品与可卡因或甲基苯丙胺、鸦片或乙醇混合的安全性。仅出于成本估算的目的，假设由COR指定的测试品将以口服方式给药，并与可卡因或甲基苯丙胺(交互作用物件)通过静脉(尾静脉)注射进行联合测试，研究将分两次进行。测试物品和互动物品之间的间隔为2小时。应评估对致命性、行为(包括抽搐)和临床观察的影响。在这项研究中，将有12个处理组，每个组由10只雄性大鼠组成。在给药当天，每隔4小时观察一次动物的治疗效果，此后每天观察一次，持续3天。这些动物将在服药后大约4天被人道处死。应对所有试品和交互物品给药溶液进行检测，以验证其身份和浓度。奈达需要一份完整的研究报告。研究的进行和报告应符合良好实验室规范(GLP)指南(CFR标题21，第58部分)。

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).