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.

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 )组合微生物。这项复杂的任务将得到来自学术界的五个核心地点的支持[纽约血液中心（C）； NIH/NCI（D）和商业公司[粘合剂研究（A）；陶氏药物 科学（b）：生物化（e）;]。这些公司站点的主要作用是目标1通过基于迭代研究的科学，技术，分析和法规支持，用于IV项目（帽菌霉霉素膜的临床开发）。一旦计划项目的目标1在实验室规模和动物实验中完成，目标我还将涵盖组合杀菌剂。 Core BC与Core BA合作，将提供Jiang（Cap Film＆Microbicide Comminations的体外功效）和Harouse项目（在Vivo的体外功效）的项目 帽和组合膜的安全性和功效）具有定义的帽膜，菌心组合和组合膜，以建立安全性，有效性TN Vitro和动物模型以及这些产品的粘膜分布。 BC Core BC，与Core Ba合作。 BB和BD还将提供分析支持。核心BD将提供与ZnFis相关的ZNFIS和分析和法规支持。