SHELF LIFE EVALUATION OF CLINICAL DRUGS

临床药物的保质期评估

• 批准号: 2300393
• 负责人: JAMES J PRICE
• 金额: $ 31.58万
• 依托单位: UNIVERSITY OF GEORGIA
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-05-16 至 1997-04-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2300393
• 关键词: chemical information system; chemical registry /resource; drug preservation; drug quality /standard

The contractor shall 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 Pharmaceutical Resources Branch. These reports will be used for providing NCI and its investigators with information regarding the proper storage and handling of various drug products under investigation, for determining appropriate expiration dates for the products, and to support NCI's Investigational New Drug Applications (INDs) files 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).

承包商应适当存放，充分测试和评估货架 研究性临床药物制剂的生命样本，包括 注射产品和口服剂型，并报告此类结果 测试药物资源分支。 这些报告将被使用 为了向NCI及其调查人员提供有关 适当储存和处理各种正在研究的药物， 用于确定产品的适当到期日期，并 支持NCI的调查新药物应用程序（IND）文件 食品和药物管理局（FDA）。 此外，该项目需要 FDA电流定义的储备样品的存储和检查 良好的制造实践法规（CGMP）。