Administrative

行政的

基本信息

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
项目类别：
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

项目摘要

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.

项目摘要（参见说明）：拟议的项目包括杀微生物剂产品开发与独特地输送到阴道和直肠室的单剂和组合杀微生物剂产品之间的复杂相互作用，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发挥作用的工具。了解外植体、非人灵长类动物和人类的杀菌剂剂量、药代动力学和药效学，以及可接受性/用户感知。该产品开发组件包括双重作用入口和非核苷类逆转录酶抑制剂 IQP-0528（一种对 HIV-1 临床毒株具有亚纳摩尔活性的嘧啶二酮），可单独使用或与替诺福韦联合使用。腔室 (DuoGels) 凝胶和智能栓剂/子宫托 (智能栓剂) 输送工具，可在阴道和直肠腔室中给药。我们相信产品开发（新型杀菌剂、组合产品、长效递送技术、双隔室递送技术）和杀菌剂科学（剂量估计、药代动力学、药效学、体外、离体和体内建模、精液和阴道液的影响、可接受性测试方法）使该提案对于杀微生物剂科学领域的下一代杀微生物剂产品的开发具有本质上的新颖性和重要意义。总体而言，该项目还提供了新型 PK/PD 测定、新型单一和组合产品、新型递送策略和新型杀菌剂开发进展的开发，以更好地了解和优先考虑杀菌剂产品的开发和使用。行政核心将在确保本合作协议中各个项目和核心的顺利整合方面发挥至关重要的作用研究计划。该项目的成功实施需要各个项目、核心和企业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。