Development and Production of Parenteral Dosage Forms for Clinical Studies

该项目的主要目标是开发和生产供人类使用的药学上可接受的非肠外剂量形式的癌症药物。由NCI选择的某些药物，DCTD将被指定作为非注射产品进行开发和生产。批量应从小批量（少于100个单位）到中等批量，用于I期和II期试验；然而，也有可能扩大到大批量（10到30,000个或更多），用于后期II/III期试验。承包商应提供服务、合格的人员、材料和一个完整的、持续的和完全可操作的设施，包括所有必要的设备，用于无菌、冻干、液体灌装和其他注射剂型的生产和测试。该设施和设备应符合并按照FDA规定的现行良好生产规范进行人用药品生产。具有处理、开发和生产细胞毒性药物的能力。

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.