SHELF LIFE EVALUATION OF CLINICAL DRUGS

临床药物的保质期评估

• 批准号: 3614844
• 负责人: DONALD E CADWALLADER
• 金额: $ 24.89万
• 依托单位: UNIVERSITY OF GEORGIA
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-08-16 至 1992-08-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3614844
• 关键词: antineoplastics; dosage forms; drug preservation; drug quality /standard; packaging material

The objective of this contract effort is to properly store, adequately test and evaluate shelf life samples of investigational clinical drug formulations, including both injectable products and oral dosage forms, and report the results of such testing to the NCI. These reports will be used for providing NCI and its investigators with information regarding the proper storage and handling of the various drug products under investigation, for determining appropriate expiration dates for the products, and in support of the NCI's Investigational New Drug Applications (INDs) filed with the Food and Drug Administration (FDA). In addition, the project will require storage and inspection of reserve samples as defined by the FDA Current Good Manufacturing Practices regulations (CGMPs)

该合同的目标是正确存储、 充分测试和评估研究样品的保质期 临床药物制剂，包括注射剂和 口服剂型，并将此类测试的结果报告给 国家癌症研究所。 这些报告将用于提供 NCI 及其 调查人员提供有关正确储存和 处理各种正在调查的药品， 确定产品的适当有效期，并 支持 NCI 的研究性新药申请 (IND) 向食品和药物管理局 (FDA) 备案。 此外， 该项目需要储备样品的储存和检验 根据 FDA 现行良好生产规范的定义 法规（CGMP）