Development and Production of Parenteral Dosage Forms for Clinical Studies

用于临床研究的肠胃外剂型的开发和生产

• 批准号: 8020413
• 负责人: TIMOTHY SMITH
• 金额: $ 69万
• 依托单位: BEN VENUE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-31 至 2013-12-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8020413
• 关键词: Clinical; Clinical Research; Contractor; Contracts; Data; Development; Division of Cancer Treatment and Diagnosis; Dosage Forms; Emulsions; Equipment; Evaluation; Freeze Drying; Gas-Liquid Chromatography; Government; Health Personnel; Housing; Label; Letters; Liposomes; Liquid substance; Malignant Neoplasms; National Cancer Institute; New Agents; Nurses; Performance; Pharmaceutical Preparations; Pharmacists; Pharmacologic Substance; Phase I/II Trial; Phase II/III Trial; Physicians; Production; Quality Control; Spectrum Analysis; Sterility; Testing; United States Food and Drug Administration; instrumentation; manufacturing facility; sterility testing; ultraviolet

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.

该项目的主要目标是开发和生产药学上可接受的具有抗癌活性的有前景的新制剂的非肠道剂型。由NCI癌症治疗和诊断部(DCTD)癌症操作委员会选定的某些药物将被指定作为非肠道产品(主要是无菌冷冻干燥产品)进行开发和生产。用于第一阶段和第二阶段试验的批次应从小批次(少于100个单位)到中等大小批次；然而，也可以升级到大批次(1-10,000个或更多单位)以用于高级第二阶段/第三阶段试验。开发和生产其他药物剂型(即大容量注射用制剂、无菌乳剂、脂质体和无菌微分散体)的能力是可取的，但不是必需的。 从本合同获得的数据可能1)用于支持国家癌症研究所向美国食品和药物管理局以及外国公司提交的IND申请，2)提供给其他NCI承包商，从事这些剂型的大规模剂型制造和分析评估，3)提供给在临床环境中处理这些产品的医生、药剂师、护士和其他医务人员。