DEVELOPMENT AND PRODUCTION OF PARENTERAL DOSAGE FORMS

点击翻译按钮获取中文摘要

The primary objective of this project is to develop and produce Pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer or the HIV virus. Certain agents selected by the NCI, DCTDC, Cancer and AIDS operating committees will be assigned for development and production as parenteral products (primarily sterile freeze dried products). Batch sizes will range from small development batches (less than 100) to intermediate size batches to be used in Phase I and II trials; however, escalation to large batch Size (10-30,000 or more) for Phase III/IV trials and Group C distribution is possible. It is estimated that the successful offerors must be prepared to supply more than five-hundred thousand parenteral dosage units each year. The capability to develop and manufacture other pharmaceutical dosage form (i.e. large volume parental, sterile emulsions, sterile micro-dispersions, etc) is desirable but not essential. Data obtained from the contract will: 1) be used to support IND applications submitted by the National Cancer Institute to the U.S. Food and Drug Administration, 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, and nurses and other medical personnel handling these products in a clinical setting.