Formulation Development and Clinical Manufacturing: Manufacture of TLC-ART101 Bulk Product for Clinical Trials

制剂开发和临床制造：用于临床试验的TLC-ART101散装产品的制造

• 批准号: 10449189
• 负责人: JON MIRSALIS
• 金额: $ 29.48万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-15 至 2021-12-24
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10449189
• 关键词: Acquired Immunodeficiency Syndrome; Anti-Retroviral Agents; Clinical; Clinical Trials; Contracts; Cyclic GMP; Development; Development Plans; Excipients; Formulation; HIV; HIV Infections; HIV therapy; Injectable; Intervention; Lipids; Lopinavir/Ritonavir; National Institute of Allergy and Infectious Disease; Pharmacologic Substance; Pharmacology and Toxicology; Preparation; Regulation; Research Personnel; Services; Sterility; Suspensions; Tenofovir; Therapeutic Agents; United States Dept. of Health and Human Services; United States National Institutes of Health; antiretroviral therapy; clinical investigation; co-infection; drug development; microbicide; prevent; sexual HIV transmission; transmission process

The Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), maintains a portfolio of contracts to support the development of (1) therapies for HIV infection and its complications and coinfections, and (2) microbicides for preventing the sexual transmission of HIV. Services provided under this contract assist investigators in academic settings and small pharmaceutical firms in filling specific gaps in their drug development plan as they advance their product towards clinical investigation of therapies for HIV infection and interventions to prevent HIV transmission. Activities will include the development of formulations of potential therapeutic agents and microbicides. In addition studies will be conducted to assess the pharmacology and toxicology of potential therapeutic agents and microbicides.

美国国家过敏症和传染病研究所（NIAID）、美国国立卫生研究院（NIH）、卫生与公众服务部（DHHS）的艾滋病司（DAIDS）持有一系列合同，以支持开发（1）艾滋病毒感染及其并发症和合并感染的治疗方法，以及（2）预防艾滋病毒性传播的杀微生物剂。根据该合同提供的服务有助于学术机构和小型制药公司的研究人员填补其药物开发计划中的具体空白，因为他们将其产品推向艾滋病毒感染治疗和预防艾滋病毒传播干预措施的临床研究。活动将包括开发潜在治疗剂和杀微生物剂的配方。此外，还将进行研究，以评估潜在治疗剂和杀微生物剂的药理学和毒理学。