SYNTHESIS AND DISTRIBUTION OF DRUGS OF ABUSE AND RELATED COMPOUNDS. N01DA-18-8944. PERIOD OF PERFORMANCE: JUNE 9, 2018 - JUNE 8, 2022

滥用药物及相关化合物的合成和分布。

• 批准号: 10414865
• 负责人: HAYES JAMES
• 金额: $ 39.72万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10414865
• 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; Performance; 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）。承包商应从 NIMH 化学合成和药物供应 (CSDSP) 库存中接收、储存和维护化合物以及分析和技术信息（从合同 HHSN271201400001l 过渡）。 对库存中化合物的请求应通过由承包商维护的可公开访问的计划网站 (https://nimh-repository.rti.org/) 提交给承包商。承包商应维护包含以下信息的网站：CSDSP 的描述、NIMH 库存中可用的最新化合物清单以及提交化学合成或化合物请求的程序和表格。 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，并持续开展研发工作。经 COR 批准后，应在请求化合物时进行评估。 纯度评估的需要应基于化合物上次评估以来的日期以及化合物在最佳保质期条件下的已知稳定性。如果发生化学或放射化学变质，应进行重新净化。 承包商应识别、获取和更新药物供应清单（研究资源/目录），其中包含新的或最新发现的可用于药物滥用研究的化合物以及该计划的任何新指南。