SHELF LIFE EVALUATION OF CLINICAL DRUGS

临床药物的保质期评价

• 批准号: 3609950
• 负责人: DONALD E CADWALLADER
• 金额: $ 18.45万
• 依托单位: UNIVERSITY OF GEORGIA
• 依托单位国家: 美国
• 财政年份: 1982
• 资助国家: 美国
• 起止时间: 1982-08-16 至 1987-08-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3609950
• 关键词: cryopreservation; drug preservation; drug quality /standard; gas chromatography; heat; high performance liquid chromatography; humidity; nuclear magnetic resonance spectroscopy; paper chromatography; spectrometry

Provide adequate controlled facilities for the storage of samples from approximately 30 to 40 lots of clinical drugs peryear under freezer storage refrigeration, controlled room temparature, and elevated temperature (50 C) conditions. Further performance of this project will require in-house, up-to-date analytical and pharmaceutical testing equipment and facilities to adequately evaluate the shelf life of each of the clinical products. The testing requirements and protocols will be determined by NCI in accordance with FDA's Current Good Manufacturing Practices. Testing intervals will normally be 0, 3, 6, 9, 12, 18, 24, 36, 48, and 60 months of storage at one or more of the storage conditions for each of the lots of clinical drugs evaluation. However, fewer or more tests may be assigned by NCI should the drug warrant such schedule modification.

提供足够的受控设施来储存来自 每年冷冻储存约30至40批临床药品 冷藏、受控室温和高温（50°C） 状况。 该项目的进一步实施将需要内部、 最新的分析和制药测试设备和设施 充分评估每种临床产品的保质期。 测试要求和协议将由 NCI 确定 符合 FDA 现行良好生产规范。 测试 间隔通常为 0、3、6、9、12、18、24、36、48 和 60 个月 每个批次的一种或多种储存条件下的储存 临床药物评价。 然而，可以分配更少或更多的测试 NCI 应批准该药物进行此类时间表修改。