Administrative

行政的

• 批准号: 8405107
• 负责人: Robert Walter Buckheit
• 金额: $ 9.54万
• 依托单位: IMQUEST BIOSCIENCES
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-22 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8405107
• 关键词: Biological Assay; Budgets; Centers for Disease Control and Prevention (U.S.); Clinical; Communication; Complex; Data; Development; Dose; Drug Kinetics; Ensure; Evaluation; Expenditure; Gel; Goals; Grant; HIV-1; Hospitals; Human; Human Resources; In Vitro; Individual; Institutes; Instruction; Methods; National Institute of Allergy and Infectious Disease; Participant; Perception; Performance; Pessaries; Pharmacodynamics; Pharmacologic Substance; Play; Program Evaluation; Progress Reports; Reporting; Research; Research Activity; Role; Schedule; Science; Scientist; Seminal fluid; Summary Reports; Suppositories; Technology; Teleconferences; Tenofovir; Testing; TimeLine; U-Series Cooperative Agreements; United States National Institutes of Health; Universities; Utah; Vagina; Woman; Writing; cost effective; in vivo Model; meetings; member; microbicide; new product development; next generation; non-nucleoside reverse transcriptase inhibitors; nonhuman primate; novel; novel strategies; product development; programs; rectal; research and development; symposium; tool; vaginal fluid

PROJECT SUMMARY (See instructions): The proposed Project includes a complex interplay of both microbicide product development with single agent and combination microbicide products uniquely delivered to both the vaginal and rectal compartments, as well as microbicide science advancement in which the active microbicides will be utilized as tools to better understand microbicide dosing, pharmacokinetics and pharmacodynamics in explants, nonhuman primates and humans, and acceptability/user perception. The product development components consist of the dual acting entry and nonnucleoside reverse transcriptase inhibitor IQP-0528 (a pyrimidinedione with subnanomolar activity against clinical strains of HIV-1) used alone and in combination with tenofovir in dual compartment (DuoGels) gels and smart suppository/pessary (Smart Suppository) delivery vehicles that will enable dosing in both vaginal and rectal compartments. We believe the potential advancements in product development (new microbicide agents, combination products, long lasting delivery technology, dual compartment delivery technology) and microbicide science (dosing estimation, pharmacokinetics, pharmacodynamics, in vitro, ex vivo, and in vivo modeling, effects of seminal and vaginal fluids, acceptability testing methods) make this proposal both inherently novel and important to the field of microbicide science in regard to the development of the next generation of microbicide products. In whole, the Project also provides for the development of novel PK/PD assays, novel single and combination products, novel delivery strategies, and novel microbicide development advancements to better understand and prioritize the development and use of microbicide products. The Administrative Core will play a critical and essential role in ensuring the smooth integration of the various Projects and Cores included in this cooperative agreement research program. The successful performance of this Project requires a high degree of communication and interaction between the various Projects, the Cores, and the Corporate Partner. The Administrative Core will be responsible for managing and enhancing this constructive and synergistic interplay between the participating scientific groups.

项目总结（见说明）： 拟议项目包括杀微生物剂产品开发与单一药剂和组合杀微生物剂产品的复杂相互作用，这些产品独特地输送到阴道和直肠隔室，以及杀微生物剂科学进步，其中活性杀微生物剂将被用作更好地 了解杀微生物剂的剂量，药代动力学和药效学在外植体，非人灵长类动物和人类，和可接受性/用户感知。产品开发组成部分包括双重作用的进入和非核苷逆转录酶抑制剂IQP-0528（一种对HIV-1临床株具有亚纳摩尔活性的嘧啶二酮）单独使用和与替诺福韦联合使用， 在一些实施方案中，本发明提供了能够在阴道隔室和直肠隔室中给药的凝胶（DuoGels）和智能栓剂/阴道托（Smart Suppository）递送载体。我们相信，产品开发（新的杀微生物剂、组合产品、长效递送技术、双室递送技术）和杀微生物剂科学（剂量估计、药代动力学、 药效学、体外、离体和体内建模、精液和阴道液的作用、可接受性测试方法）使得该提议在开发下一代杀微生物剂产品方面对杀微生物剂科学领域既具有固有的新颖性又具有重要性。总的来说，该项目还提供了新的PK/PD测定，新的单一和组合产品，新的交付策略和新的杀微生物剂开发进展的开发，以更好地了解和优先考虑杀微生物剂产品的开发和使用。行政核心将在确保本合作协议中包含的各个项目和核心的顺利整合方面发挥关键和重要的作用 研究计划。本项目的成功实施需要各项目、核心和公司合作伙伴之间的高度沟通和互动。行政核心将负责管理和加强参与科学团体之间的这种建设性和协同作用。