Drug Shelf Life Testing

药物保质期测试

• 批准号: 10337014
• 负责人: JONATHAN WHITE
• 金额: $ 23万
• 依托单位: MIDWEST RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-02-01 至 2022-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10337014
• 关键词: Dosage Forms; Drug Formulations; Investigation; Investigational New Drug Application; Life; Oral; Pharmaceutical Preparations; Reporting; Research Personnel; Sampling; Testing; United States Food and Drug Administration; clinical investigation; expiration

To evaluate shelf life of samples of investigational clinical drug formulations. The products may include parenteral , oral, and other types of dosage forms. 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, • determining appropriate expiration dates for the products, and • to support NCI's Investigational New Drug Applications (INDs) filed with the Food and Drug Administration (FDA).

评价试验用临床药物制剂样品的有效期。产品可包括肠胃外、口服和其他类型的剂型。这些报告将用于： ·向NCI及其调查人员提供有关适当储存和处理各种受调查药品的信息， ·确定产品的适当有效期，以及 ·支持NCI向美国食品药品监督管理局（FDA）提交的新药研究申请（IND）。