Preparation of Radiolabeled Materials

放射性标记材料的制备

• 批准号: 8522062
• 负责人: ANITA LEWIN
• 金额: $ 14万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-31 至 2013-07-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8522062
• 关键词: Accidents; Authorization documentation; Biological Assay; Biological Factors; Biological Monitoring; Budgets; Chemical Structure; Chemicals; Confidentiality; Contracts; Data; Development; Drug Administration Routes; Ensure; Event; Exanthema; Federal Government; Freezing; Government regulations; Human Resources; Joints; Label; Laboratories; Life; Local Government; Methods; Nature; Parents; Pharmacology and Toxicology; Preparation; Property; Qualifying; Radio; Radiolabeled; Refuse Disposal; Reporting; Research Personnel; Route; Safety; Shipping; Ships; Site; Specific qualifier value; State Government; Time; United States National Institutes of Health; Waste Management; Work; Writing; cold temperature; cost; drug development; foot; in vivo; pre-clinical; programs; radiotracer; repository

The contract encompasses two major activities: synthesis and repository-related activities. The latter includes deep freeze storage, analysis, purification and shipping of radiolabeled compounds. About 70% of the annual budget is utilized for synthesis and the remainder is required to cover expenses incurred to maintain the repository-related activities including the deep freeze storage facility (-70 degrees Celsius) radio-safety and radio-waste disposal. The estimated value of the stored compounds now number 115 exceeds $1,000,000. The compounds selected for syntheses involve both synthetics and natural products and cover a wide variety of chemical structures and complexity. The major focus will be on the synthesis of 3H-labeled compounds of high specific activity as well as 14C-labeled compounds. New radiolabeled syntheses are initiated upon program request derived from RAID program, the Drug Development Group (DDG), Operating Committee (OC), and Joint Development Committee (JDC) initiatives, and also from NIH RAID program. The radiolabeled compounds are used primarily to support preclinical pharmacology, toxicology, and mechanism of action studies. These studies are critical for successful drug development since they help the investigators define important properties, such as the in vivo fate of the parent compound. Furthermore, radiolabeled agents are used to identify metabolites, select the optimal route of drug administration, and monitor the biological disposition of compounds.

该合同包括两项主要活动：综合活动和与存储库相关的活动。后者包括放射性标记化合物的深度冷冻储存、分析、纯化和运输。年度预算的大约 70% 用于合成，其余部分用于支付维持与储存库相关的活动所产生的费用，包括深冻储存设施（-70 摄氏度）无线电安全和无线电废物处理。目前储存的化合物有 115 种，估计价值超过 1,000,000 美元。 选择用于合成的化合物包括合成物和天然产物，涵盖多种化学结构和复杂性。主要重点是高比活性的 3H 标记化合物以及 14C 标记化合物的合成。新的放射性标记合成是根据 RAID 计划、药物开发小组 (DDG)、操作委员会 (OC) 和联合开发委员会 (JDC) 倡议以及 NIH RAID 计划的计划请求启动的。 放射性标记化合物主要用于支持临床前药理学、毒理学和作用机制研究。这些研究对于成功的药物开发至关重要，因为它们帮助研究人员确定重要的特性，例如母体化合物的体内命运。此外，放射性标记试剂用于识别代谢物、选择最佳给药途径并监测化合物的生物处置。