LOT-RELEASE TEST VALIDATION STRATEGIES FOR BIOLOGICS

生物制剂批签发测试验证策略

• 批准号: 6293825
• 负责人: ROLF E TAFFS
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6293825
• 关键词: analytical method; drug design /synthesis /production; drug quality /standard; method development; vaccine development; vaccines

Validation is required for tests used in lot release of vaccines. Validation parameters differ depending on the nature of the test and its application. The goal of this project is to develop suitable strategies for validating tests that can be applied to assays under development in the product laboratories and divisions in OVRR as well as to tests that must be established in the Quality Control Unit in DVP.

需要对批放行中使用的检测进行确认 疫苗。验证参数因性质而异 测试及其应用。这个项目的目标是 制定合适的策略来验证测试， 适用于产品中正在开发的试验 OVRR的实验室和部门以及测试， 必须在DVP的质量控制部门建立。