Task 03/13: Product Development Plans for Vaccines

新发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/或疗法的功效测试，包括支持产品许可的GLP研究。对小动物有效的疫苗和疗法可在非人类灵长类动物模型中进一步试验。该合同还规定在适当情况下根据GLP在小动物和非人灵长类动物中进行疫苗的安全性和免疫原性测试，包括体液和细胞免疫。此外，它还可以在适当的情况下，根据GLP在小动物和非人类灵长类动物中进行治疗药物的安全性和药理学测试。

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.