Task V11: General Safety Toxicity Testing

用于传染病的疫苗和其他生物制剂的评估和测试服务（ETS）合同提供各种产品开发服务，从早期可行性研究到提交生物许可证申请（BLA）和/或研究新药（IND）申请所需的活动。任务领域包括：1)行政管理和技术支持，包括培训和研讨会，质量监督和管理（现场访问、关键阶段审核和最终研究报告审核），2)免疫测定的开发、鉴定和验证，3)免疫原性和有效性测试，4)非临床和临床样本测试，5)安全性/毒理学研究。这些服务将促进开发和引进新的候选疫苗和生物制剂（由CBER管理），以防止生物恐怖主义和新出现和再出现的传染病的潜在病原体。

The Evaluation and Testing Services (ETS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services from early feasibility studies through activities required for the submission of Biologic License Application (BLA) and/or Investigational New Drug (IND) applications. Task areas include: 1) administrative management and technical support including training and workshops, and quality oversight and management (site visits, critical stage audits, and final study report audits), 2) development, qualification and validation of immune assays, 3) immunogenicity and efficacy testing, 4) non-clinical and clinical sample testing, and 5) safety/toxicology studies. These services will facilitate the development and introduction of new vaccine candidates and biologics (regulated by CBER) against potential agents of bioterrorism and emerging and re-emerging infectious diseases.