Analysis of Anti-Cancer Chemicals and Pharmaceuctical Formulations

抗癌化学品和药物制剂的分析

• 批准号: 8089742
• 负责人: JENNIE WANG
• 金额: $ 20万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-06-01 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8089742
• 关键词: Chemicals; Clinical; Clinical Research; Data; Drug Formulations; Investigational Drugs; Malignant Neoplasms; Pharmaceutical Preparations; Quality Control; Reporting; Techniques; United States Food and Drug Administration; antitumor agent; antitumor drug; drug candidate; instrumentation; pre-clinical

The project is involved in the analytical assessment of bulk drug substances and clinical drug products to be used in pre-clinical and clinical studies of anti-tumor drug candidates. Physical and chemical data provided in the study reports will be supplied to the Food and Drug Administration (FDA) as part of the Investigational New Drug (IND) filings for anti-tumor agents.

该项目涉及将用于抗肿瘤候选药物的临床前和临床研究的原料药和临床药物产品的分析评估。研究报告中提供的物理和化学数据将作为抗肿瘤药物研究新药(IND)文件的一部分提供给食品和药物管理局(FDA)。