Task 2/F04: Pharmacokinetic and Safety/Tox Testing for Therapeutics

任务 2/F04：治疗药物的药代动力学和安全性/毒性测试

• 批准号: 8338703
• 负责人: MARA KUMMINS
• 金额: $ 19.29万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2012-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8338703
• 关键词: Animal Model; Animals; Anthrax disease; Cellular Immunity; Contracts; Development; Disease; Drug Kinetics; Humoral Immunities; In Vitro; Licensure; Modeling; Pharmacology; Plague; Safety; Standardization; Testing; Therapeutic; Toxicology; Tularemia; Vaccines; biodefense; efficacy testing; immunogenicity; nonhuman primate; therapeutic vaccine; vaccine safety

The In Vitro and Animal Models for Emerging Diseases and Biodefense contract provides the development and standardization of small animal and non-human primate models, and may include efficacy testing of vaccines and/or therapeutics, including GLP studies to support product licensure. Vaccines and therapeutics which are efficacious in small animals may be further tested in non-human primate models. This contract also provides testing of vaccines for safety and immunogenicity, to include humoral and cellular immunity, in small animals as well as non-human primates, under GLP where appropriate. In addition, it can perform testing of therapeutics for safety and pharmacology, in small animals as well as non-human primates, under GLP where appropriate.

新兴疾病和生物防御的体外和动物模型合同提供了小动物和非人灵长类动物模型的开发和标准化，可能包括疫苗和/或治疗剂的有效性测试，包括GLP研究以支持产品许可。在小动物中有效的疫苗和治疗剂可以在非人灵长类动物模型中进一步测试。该合同还提供了在GLP下在小动物以及非人灵长类动物中进行的疫苗安全性和免疫原性测试，包括体液和细胞免疫。此外，它可以在适当的情况下根据GLP在小动物以及非人灵长类动物中进行治疗剂的安全性和药理学测试。