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

新出现疾病和生物防御的体外和动物模型合同提供小动物和非人类灵长类动物模型的开发和标准化，并可能包括疫苗和/或疗法的有效性测试，包括支持产品许可的GLP研究。在小动物身上有效的疫苗和疗法可能会在非人类灵长类动物模型中进一步测试。该合同还提供疫苗的安全性和免疫原性测试，包括在小动物和非人类灵长类动物中的体液和细胞免疫，在适当的情况下，根据GLP。此外，它还可以根据GLP在适当的情况下在小动物和非人类灵长类动物身上进行治疗安全性和药理学的测试。

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.