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: 8740587
• 负责人: UNKNOWN UNKNOWN
• 金额: $ 0.1万
• 依托单位: PIRAMAL PHARMA SOLUTIONS INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2013-10-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8740587
• 关键词: Antineoplastic Agents; Clinical Research; Contractor; Contracts; 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; meetings

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.

该项目的主要目的是开发和生产用于人类的癌症药物的药学上可接受的肠胃外剂型。NCI、DCTD选择的某些药物将作为胃肠外产品进行开发和生产。批量范围应从小批量（小于100个单位）到用于I期和II期试验的中等批量;但是，对于晚期II/III期试验，也可以增加到大批量（10至30，000个单位或更多）。承包商应提供服务、合格人员、材料和完整的、持续的和全面运行的设施，包括无菌、冻干、液体填充和其他注射剂型的生产和测试的所有必要设备。This facili？设备和设备应符合FDA规定的现行药品生产质量管理规范，并按照FDA规定的现行药品生产质量管理规范进行维护。他们应能够处理、开发和生产细胞毒性药物。