Pharmaceutical and Regulatory Core

要成功地完成这项工作，需要获得药物物质和处方药物产品 中心助学金申请。此外，必须正确填写所有必需的法规文件，并 向FDA提交文件，以测试薄膜和凝胶配方进入第一阶段临床测试。该计划的总体目标 药学和监管核心(核心C)是提供药品和监管支持 本拨款申请的项目1、2、3、4和核心B。核心将协调收购， UC781和替诺福韦(TFV)药材、UC781和TFV凝胶制品的分销和/或制造， 以及UC781和TFV GMP薄膜，用于所有项目和核心。制药核心公司将协助 协调项目3和4的临床用品的生产、包装和标签。GMP凝胶 含有UC781或TFV的产品将通过Conrad从现有的临床供应中供应。GMP 薄膜产品将在合适的合同制造商生产，如MonoSol Rx或LTS 罗曼。核心C将管理批次记录的准备、胶片的制造、发行测试和 支持稳定性研究。Core C还将通过电影产品管理GLP动物毒理学研究，以 支持第一阶段临床测试。Conrad目前持有TFV凝胶的IND之一，还持有 用于UC781阴道凝胶的IND。核心C将汇编所有必需的数据和协议，以便向 FDA为每种药物提供支持，以支持本中心拨款申请下计划的所有临床试验活动。最后， Core C将为所有患者提供临床方案开发和患者安全监测方面的帮助 项目3和4中的人体研究。Conrad在Core内所有计划的活动中拥有丰富的经验 C.核心C的活动将确保彻底和及时完成目标里程碑。

Access to drug substance and formulated drug product are required for the successful completion of this Center Grant application. In addition, all required regulatory documention must be properly completed and filed with the FDA to test the film and gel formulations into Phase 1 clinical testing. The overall goal of the Pharmacuetical and Regulatory Core (Core C) is to provide pharmaceutical product and regulatory support for Projects 1, 2, 3, and 4 and Core B of this grant application. The Core will coordinate the acquisition, distribution, and/or manufacture of UC781 and tenofovir (TFV) drug substance, UC781 and TFV gel product, and UC781 and TFV GMP film for all projects and cores. The Pharmaceutical Core will assist in coordination of the manufacture, packaging, and labeling of clinical supplies for Projects 3 and 4. GMP gel products containing UC781 or TFV will be supplied through CONRAD from existing clinical supplies. GMP film product will will be manufactured at a suitable contract manufacturer such as MonoSol Rx or LTS Lohmann. Core C will manage preparation of batch records, manufacturing of films, release testing, and supporting stability studies. Core C will also manage GLP animal toxicology studies with film products to suppport Phase 1 clinical testing. CONRAD currently holds one of the INDs for TFV gel and also holds the IND for UC781 vaginal gel. Core C will compile all required data and protocols to file amendments with the FDA for each drug in support of all clinical trial activity planned under this Center Grant application. Finally, Core C will provide assistance with clinical protocol development as well as patient safety monitoring for all human studies in Projects 3 and 4. CONRAD has significant experience in all planned activities within Core C. The activities of Core C will ensure thorough and timely completion of targeted milestones.