PRECLINICAL TOXICOLOGY & PHARMACOLOGY OF DRUGS DEVELOPED

临床前毒理学

• 批准号: 6221364
• 负责人: JOHN G PAGE
• 金额: $ 80.17万
• 依托单位: SOUTHERN RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-01-15 至 2003-01-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6221364
• 关键词: AIDS therapy; Primates; Rodentias; antiAIDS agent; antineoplastics; dogs; dosage; drug administration routes; drug screening /evaluation; mass spectrometry; neoplasm /cancer; neoplasm /cancer chemotherapy; neoplasm /cancer pharmacology; nonhuman therapy evaluation; nuclear magnetic resonance spectroscopy; pharmacokinetics; pharmacology; toxicology

The objective of this contract is to acquire pharmacologic and toxicologic data on new drugs for the treatment of Cancer and the Acquired Immunodeficiency Syndrome (AIDS) and AIDS-related illnesses. The data will be included in an Investigational New Drug (IND) application to the FDA which is required prior to the initiation of human clinical trials. Level A contract is 46,875 hours over 5 years. Level B contract is 93,750 hours over 5 years. This contract will be awarded at Level B because the laboratory has the capability, expertise and experience to do the amount of work required.

该合同的目的是获得药理学和 用于治疗癌症的新药的毒理学数据和 获得性免疫缺陷综合症（艾滋病）和艾滋病相关疾病。 这些数据将被纳入研究性新药（IND）中 在启动之前向FDA提出的申请 人体临床试验 A级合同为5年46，875小时。 B级合同是 5年93,750小时。 本合同将按B级授予 因为实验室有能力、专业知识和经验， 完成所需的工作量。