CORE--Technology and Regulatory Core Unit

CORE--技术与监管核心单元

• 批准号: 6809180
• 负责人: A ROBERT ROBERT NEURATH
• 金额: $ 23.4万
• 依托单位: NEW YORK BLOOD CENTER
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6809180
• 关键词: analytical method; antiinfective agents; biomedical facility; cooperative study; cyclodextrins; drug design /synthesis /production; drug interactions; drug screening /evaluation; health related legal; inhibitor /antagonist; method development; molecular film; phthalates; reverse transcriptase inhibitors; technology /technique; topical drug application; virus replication

This core ("Core B") will enable the two goals of the entire project: (1) provide knowledge needed for commercial mass production of CAP films and (2) establish optimal parameters for cellulose acetate phthalate (CAP) / zinc finger inhibitor (ZnFI) / reverse transcriptase (RT) inhibitor UC781 / hydroxypropyl-beta-cyclodextrin (HP-beta-CD ) combination microbicides. This complex task will be supported by five Core sites from academia [New York Blood Center (c); NIH/NCI (d)] and commercial companies [Adhesives Research (a); Dow Pharmaceutical Sciences (b): Bioqual (e);]. The primary role of these company sites is goal 1 by providing scientific, technological, analytical and regulatory support, based on iterative studies, for Project IV (Clinical development of CAP microbicide films). Once goal 1 of the Program Project is accomplished in laboratory scale and animal experiments, goal I will also encompass combination microbicides. Core Bc, in collaboration with Core Ba, will provide Project by Jiang (in vitro efficacy of CAP film & microbicide combinations)and Project by Harouse (in vivo safety and efficacy of CAP and combination films) with defined CAP films, microbicide combinations, and combination films to establish the safety, efficacy tn vitro and in animal models, and mucosal distribution of these products. Core Bc, in collaboration with Core Ba. Bb and Bd, will also provide analytical support. Core Bd will provide ZnFIs and analytical and regulatory support related to ZnFIs.

这一核心(“核心B”)将实现整个项目的两个目标：(1)提供商业批量生产CAP膜所需的知识；(2)建立醋酸酯纤维素(CAP)/锌指抑制剂(ZnFI)/逆转录酶(RT)抑制剂UC781/羟丙基-β-环糊精(HP-β-CD)组合杀菌剂的最佳参数。这项复杂的任务将得到来自学术界[纽约血液中心(C)；NIH/NCI(D)]和商业公司[粘合剂研究(A)；陶氏制药(Dow Pharmtics)]的五个核心站点的支持 科学(B)：生物(E)；]。这些公司网站的主要作用是通过在迭代研究的基础上为项目IV(CAP杀微生物剂膜的临床开发)提供科学、技术、分析和监管支持，从而实现目标1。一旦计划项目的目标1在实验室规模和动物实验中实现，目标1也将包括组合杀菌剂。CORE BC将与CORE BA合作提供Project by酱(CAP膜和杀微生物剂组合的体外功效)和Project by Harouse(体内 安全性和有效性)与确定的CAP膜、杀微生物剂组合和组合膜，以确定这些产品在体外和动物模型中的安全性、有效性和粘膜分布。核心BC，与核心BA合作。Bb和bd，也将提供分析支持。核心Bd将提供锌离子注入以及与锌离子注入离子有关的分析和监管支持。