Purpose Interaction Safety Studies in Rats and Dogs, Period of Performance: 03/25/2020-03/24/2021. NIDA Ref. No. N01DA-18-8939. FY20

在这项任务指令下，SRI提议在大鼠和狗身上进行一项相互作用安全性研究，以响应TORFP。这些研究的目的是确定试验品与滥用物质（相互作用品）结合使用的安全性。预计执行时间为2020年1月15日至2021年1月14日；但是，实际的开始日期取决于从客户处收到测试文章。SRI将进行活动A， GLP大鼠相互作用研究。活动B， GLP狗遥测研究，将外包给查尔斯河实验室（CRL），因为目前SRI的硬件和软件需要由供应商进行更新，并在进行任何工作之前由SRI的QAU进行验证。俄亥俄州亚什兰的CRL拥有经过验证的设备和软件来执行NIDA所需的活动。由于这些原因，考虑到NIDA的成本和时间，SRI决定将GLP狗遥测研究外包给经常进行此类研究的实验室，并且之前已经进行了类似研究设计的NIDA研究。SRI将担任本研究的研究监督员。

Under this task order, SRI proposes to perform one interaction safety study in rats and one cardiovascular safety interaction study in dogs in response to the TORFP. The objectives of these studies are to determine the safety of a test article in combination with an abused substance (interaction article). The estimated period of performance is January 15, 2020 through January 14, 2021; however, the actual start date is contingent upon receipt of test articles from the client. SRI will perform the Activity A, GLP rat interaction study. The Activity B, GLP dog telemetry study, will be outsourced to Charles River Laboratories (CRL) as the hardware and software currently with SRI needs to be updated by the vendors and validated by SRI’s QAU before any work can be performed. CRL at Ashland, OH site has the validated equipment and software to perform the NIDA required activities. Due to these reasons and in the interest of cost and time for the NIDA, SRI has decided to outsource this GLP dog telemetry study to the lab that performs this type of study frequently and has previously conducted a NIDA study with similar study design. SRI will serve as the study monitor for the study.