CORE--Technology and Regulatory Core Unit

该核心（“核心B”）将实现整个项目的两个目标：（1）提供CAP膜的商业化大规模生产所需的知识和（2）建立邻苯二甲酸乙酸纤维素（CAP）/锌指抑制剂（ZnFI）/逆转录酶（RT）抑制剂UC 781/羟丙基-β-环糊精（HP-β-CD）组合杀微生物剂的最佳参数。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 Pharmaceutical）]的五个核心研究中心的支持 科学（B）：生物鉴定（e）;]。这些公司网站的主要作用是目标1，根据迭代研究，为项目IV（CAP杀微生物剂薄膜的临床开发）提供科学、技术、分析和监管支持。一旦在实验室规模和动物实验中完成了计划项目的目标1，目标I也将包括组合杀微生物剂。Core Bc将与Core Ba合作，提供Jiang的项目（CAP膜和杀微生物剂组合的体外功效）和Harouse的项目（体内 CAP和组合膜的安全性和有效性），以确定这些产品在体外和动物模型中的安全性、有效性以及粘膜分布。Core Bc，与Core Ba合作。Bb和Bd也将提供分析支持。Core Bd将提供ZnFI以及与ZnFI相关的分析和监管支持。

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.