Development and Production of Parenteral Dosage Forms for Clinical Studies

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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.