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 promising new agents with activity against cancer. Certain agents selected by the NCI, Division of Cancer Treatment and Diagnosis (DCTD) Cancer Operating Committees will be assigned for development and production as parenteral products (primarily sterile freeze dried 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 (1 - 10,000 or more units) for advanced Phase II/III trials is also possi¿ble. The capability to develop and manufacture other pharmaceutical dosage forms (i.e. large volume parenterals, sterile emulsions, liposomes and sterile micro-dispersions) is desirable but not essential. Data obtained from this contract may 1) be used to support IND applications submitted by the National Cancer Institute to the U.S. Food and Drug Administration as well as foreign agen¿cies, 2) be provided to other NCI contractors engaged in large scale dosage form manufacture and analytical evaluation of these dosage forms and 3) be provided to physicians, pharmacists, nurses, and other medical personnel handling these products in a clinical setting.