Drug Shelf Life Testing

药物保质期测试

• 批准号: 10788150
• 负责人: JONATHAN WHITE
• 金额: $ 24.3万
• 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 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10788150
• 关键词: Clinical; Dosage Forms; Drug Formulations; Investigation; Investigational New Drug Application; Life; Oral; Pharmaceutical Preparations; Reporting; Research Personnel; Sampling; Testing; United States Food and Drug Administration; 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).

评估研究性临床药物制剂样品的保质期，这些产品可能包括肠胃外、口服和其他类型的剂型。 • 向 NCI 及其调查人员提供有关正确储存和处理所调查的各种药品的信息， • 确定产品的适当有效期，以及 • 支持NCI 向食品和药物管理局(FDA) 提交的研究性新药申请(IND)。