Pharmaceutical and Regulatory Core

制药和监管核心

• 批准号: 7898242
• 负责人: DAVID R FRIEND
• 金额: $ 35.68万
• 依托单位: MAGEE-WOMEN'S RES INST AND FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-15 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7898242
• 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.

获得原料药和制剂药品是成功完成这一任务的必要条件