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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.

项目概述（见说明）：