Pharmaceutical and Regulatory Core

制药和监管核心

• 批准号: 8471648
• 负责人: DAVID R FRIEND
• 金额: $ 37.57万
• 依托单位: MAGEE-WOMEN'S RES INST AND FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-01 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8471648
• 关键词: Agreement; Amendment; Animals; Applications Grants; Clinic; Clinical; Clinical Protocols; Clinical Trials; Collaborations; Contracts; Data; Development; Drug Formulations; Ensure; Evaluation; Film; Gel; Goals; Human; Label; Long-Term Survivors; Manufacturer Name; Monitor; Nucleotides; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Preparation; Protocols documentation; Records; Reverse Transcriptase Inhibitors; Tenofovir; Testing; Toxicology; UC 781; Vaginal Gel; Work; base; experience; human study; non-nucleoside reverse transcriptase inhibitors; patient safety; product development; programs; protocol development; research clinical testing

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.

成功完成此任务需要获得原料药和配制的药品 中心拨款申请。此外，所有必需的监管文件必须正确填写并 向 FDA 提交申请，测试薄膜和凝胶配方进入第一阶段临床测试。该项目的总体目标是 制药和监管核心（核心C）是提供药品和监管支持 适用于本拨款申请的项目 1、2、3 和 4 以及核心 B。核心将协调收购， UC781 和替诺福韦 (TFV) 原料药、UC781 和 TFV 凝胶产品的分销和/或制造， UC781 和 TFV GMP 薄膜适用于所有项目和核心。制药核心将协助 协调项目 3 和 4 的临床用品的制造、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提供。良好生产规范 薄膜产品将由合适的合同制造商生产，例如 MonoSol Rx 或 LTS 洛曼。核心 C 将管理批次记录的准备、薄膜的制造、放行测试和 支持稳定性研究。 Core C 还将管理薄膜产品的 GLP 动物毒理学研究，以 支持1期临床测试。 CONRAD 目前持有 TFV 凝胶的 IND 之一，并且还持有 UC781 阴道凝胶的 IND。 Core C 将编译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， 核心 C 将为所有人提供临床方案开发以及患者安全监测方面的帮助 项目 3 和 4 中的人体研究。 CONRAD 在核心内的所有计划活动中拥有丰富的经验 C. 核心 C 的活动将确保彻底、及时地完成目标里程碑。