Task C19: Recertification for clinical use of GMP Product

任务C19：GMP产品临床使用再认证

• 批准号: 10683807
• 负责人: JON MIRSALIS
• 金额: $ 15.77万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10683807
• 关键词: Chemistry; Clinical; Communicable Diseases; Development; Development Plans; Drug Kinetics; Evaluation; In Vitro; Interventional Agent Development; Lead; Microbiology; Safety; Services; Therapeutic; Toxicology; Toxin; in vivo; pathogen; pre-clinical; product development; programs; therapeutic development

The Non-clinical Services for Development of Interventional Agents for Infectious Diseases program provides services to facilitate preclinical product development of promising therapeutics for infectious disease-causing pathogens and/or toxins. Services include: preclinical product development planning and evaluation; lead identification and development; chemistry and GMP manufacturing; in vitro and in vivo preclinical microbiological, safety, toxicology and pharmacokinetics.

传染病干预药物开发非临床服务项目提供服务，以促进有前景的传染病病原体和/或毒素治疗药物的临床前产品开发。服务包括：临床前产品开发计划和评价;先导化合物鉴定和开发;化学和GMP生产;体外和体内临床前微生物、安全性、毒理学和药代动力学。