TASK ORDER #3. NIMH. SYNTHESIS AND DISTRIBUTION OF DRUGS OF ABUSE AND RELATED COMPOUNDS.

任务单

• 批准号: 10710086
• 负责人: KATHERINE MANGUM
• 金额: $ 40.87万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-16 至 2023-06-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10710086
• 关键词: Authorization documentation; Catalogs; Chemicals; Contractor; Contracts; Deterioration; Drug abuse; Equipment and supply inventories; Evaluation; Government; Guidelines; Label; Life; National Institute of Mental Health; Peptides; Pharmaceutical Preparations; Procedures; Program Accessibility; Research; Resources; Time; Update; Work; base; chemical synthesis; drug distribution; drug of abuse; programs; radiochemical; repository; research and development; web site

The Contractor shall produce, analyze for authenticity and purity, and store labeled and unlabeled chemical compounds (including peptides) upon government authorization. The Contractor shall receive, store, and maintain compounds, along with analytical and technical information, from the NIMH Chemical Synthesis and Drug Supply (CSDSP) inventory (to be transitioned from contract HHSN271201400001l). Requests for compounds in the inventory shall be submitted to the Contractor through the publicly accessible program website which shall be maintained by the Contractor (https://nimh-repository.rti.org/). The Contractor shall maintain the website with the following information: a description of the CSDSP, a up-to-date list of compounds available in the NIMH inventory, and procedures and forms for submitting requests for chemical synthesis or for compounds. The Contractor shall perform an on going evaluation of the stability of inventoried chemical compounds (labeled and unlabeled) and maintain research and development work continuously. The evaluation shall be conducted at the time a compound is requested, upon approval of the COR. The need for purity evaluation should be based on the date since the last assessment of a compound and the known stability of the compounds under the optimal shelf-life conditions in which they are maintained. Repurification shall be carried out if chemical or radiochemical deterioration occurs. The Contractor shall identify, acquire, and update the drug supply inventory (research resources/catalog) with new or latest discovered chemical compounds useful for drug abuse research and any new guidelines for the program.

承包商应根据政府授权生产、分析真实性和纯度，并储存标记和未标记的化合物（包括肽）。承包商应接收、储存和维护NIMH化学合成和药物供应（CSDSP）库存（从合同HHSN 271201400001 l过渡）中的化合物沿着分析和技术信息。应通过承包商维护的可公开访问的计划网站（https：//nimh-repository.rti.org/）向承包商提交对库存化合物的请求。承包商应在网站上提供以下信息：CSDSP的描述、NIMH库存中可用化合物的最新列表以及提交化学合成或化合物申请的程序和表格。承包商应对库存化合物（标记和未标记）的稳定性进行持续评估，并持续进行研发工作。在COR批准后，应在申请化合物时进行评估。纯度评价的需要应基于自化合物上次评估以来的日期以及化合物在其保持的最佳有效期条件下的已知稳定性。如果发生化学或放射化学劣化，应进行再净化。承包商应识别、获取并更新药物供应库存（研究资源/目录），其中包含可用于药物滥用研究的新化合物或最新发现的化合物以及该计划的任何新指南。