DEVELOPMENT & MANUFACTURE OF ORAL DOSAGE FORMS

发展

• 批准号: 2300766
• 负责人: ROLLAND R POUST
• 金额: $ 16.78万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-30 至 1997-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2300766
• 关键词: DEVELOPMENT; MANUFACTURE; ORAL; DOSAGE; FORMS

The objective of this Contract is the development and manufacture of oral dosage forms of drugs which will be used for human clinical trials carried out under the auspices of the National Cancer Institute. Those drugs will usually consist of anti-cancer and anti-AIDS compounds. Dosage forms will include but not be limited to tablets, enteric coated tablets, capsules, soft gelatin capsules, encapsulated granules and oral powders and solutions. The contractor shall test the products from experimental and manufacturing runs for strength, identity and performance characteristics. Facilities, equipment and procedures shall conform to FDA prescribed Current Good Manufacturing Practices (CGMP).

本合同的目标是开发和制造口腔 用于人体临床试验的药物剂型 在国家癌症研究所的赞助下。 那些药物会 通常由抗癌和抗艾滋病化合物组成。 剂型将 包括但不限于片剂、肠溶片、胶囊、 软明胶胶囊、胶囊颗粒和口服粉剂以及 解决方案。承包商应对产品进行实验和测试 制造过程注重强度、特性和性能特征。 设施、设备和程序应符合FDA规定 现行良好生产规范 (CGMP)。