Development and Production of Parenteral Dosage Forms for Clinical Studies

用于临床研究的肠胃外剂型的开发和生产

• 批准号: 8739962
• 负责人: TIMOTHY SMITH
• 金额: $ 51.11万
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-31 至 2013-12-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8739962
• 关键词: Antineoplastic Agents; Clinical Research; Contractor; Cytotoxic agent; Development; Dosage Forms; Equipment; Freeze Drying; Human; Human Resources; Injectable; Liquid substance; Pharmaceutical Preparations; Phase I/II Trial; Phase II/III Trial; Production; Qualifying; Services; Sterility; Testing; drug production

The primary objective of this project is to develop and produce pharmaceutically acceptable parenteral dosage forms of cancer drugs for human use. Certain agents selected by the NCI, DCTD will be assigned for development and production as parenteral products. Batch sizes shall range from small batches (less than 100 units) to intermediate size batches to be used in Phase I and II trials; however escalation to large batch sizes (10 to 30,000 or more units) for advanced Phase II/III trials is also possible. The Contractor shall furnish services, qualified personnel, materials, and a complete, ongoing and fully operational facility including all necessary equipment for all aspects of the manufac¿ture and testing of sterile, freeze-dried, liquid- filled, and other injectable dosage forms. This facili¿ty and equipment shall conform to and be maintained for the production of human drugs in accordance with FDA prescribed Current Good Manu¿facturing Practices. They shall be capable of handling, developing, and manufacturing cytotoxic drugs.

该项目的主要目标是开发和生产药学上可接受的人类使用的抗癌药物的非肠道剂型。由NCI、DCTD选择的某些药物将被指定作为非肠道产品进行开发和生产。在第一阶段和第二阶段试验中使用的批次范围应从小批量(小于100个单位)到中等大小的批次；但是，也可以升级到大批量(10到30,000个或更多个单位)以进行高级第二阶段/第三阶段试验。承包商应提供服务、合格的人员、材料和完整的、持续的和全面运行的设施，包括无菌、冷冻干燥、液体灌装和其他可注射剂型的制造和测试的所有方面的所有必要设备。该设施和设备应符合并维护用于生产人类药物的设备，以符合FDA规定的当前良好的制造实践。具有处理、开发和制造细胞毒药物的能力。