Preclinical Pharmacology and Toxicology Studies

临床前药理学和毒理学研究

• 批准号: 7891916
• 负责人: CAROL GREEN
• 金额: $ 72.5万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-06-04 至 2011-06-03
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7891916
• 关键词: Preclinical; Pharmacology; Toxicology; Studies

Studies conducted in this preclinical pharmacology and toxicology program area are designed to satisfy requirements for Investigational New Drug (IND) applications to the FDA. All technical reports related to the pharmacology, toxicology, and safety of investigational agents are submitted to the FDA as part of the IND and Investigational Drug Brochure. Successful IND filing allows DCP to conduct clinical trials of candidate chemical, botanical, and biological chemopreventive agents and serves as a translational bridge between preclinical laboratory results and clinical trials and proof of principle studies.

在这一临床前药理学和毒理学计划领域进行的研究旨在满足FDA对研究新药(IND)申请的要求。所有与研究药物的药理学、毒理学和安全性相关的技术报告都作为IND和研究药物手册的一部分提交给FDA。成功的IND申报使DCP能够进行候选化学、植物和生物化学预防药物的临床试验，并成为临床前实验室结果与临床试验和原理研究证明之间的转换桥梁。