DEVELOPMENT AND PRODUCTION OF PARENTERAL DOSAGE FORMS

该项目的主要目标是开发和生产 药学上可接受的有前景的新的肠外剂型 具有抗癌或抗HIV病毒活性的药物。某些代理人 由NCI、DCTDC、癌症和艾滋病运营委员会选择 将以非肠外的形式分配用于开发和生产 产品(主要是无菌冷冻干燥产品)。批量大小将 范围从小的开发批次(不到100个)到中等批次 将在第一阶段和第二阶段试验中使用的大小批次；但是，升级到 第三阶段/第四阶段试验和分组的大批量(10-30,000或更多) C分布是可能的。据估计，成功的要约者 必须准备好供应超过50万 每年的非肠外剂量单位。开发和开发能力 制造其他药物剂型(即大容量 亲本、无菌乳剂、无菌微分散体等)是可取的 但不是必须的。从合同中获得的数据将：1)用于 支持国家癌症研究所提交的IND申请 提供给美国食品和药物管理局，2)提供给其他 NCI承包商从事大规模剂型制造和 对这些剂型的分析评价和3)提供给 医生、药剂师、护士和其他医务人员 在临床环境中处理这些产品。

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.