CDER abbr. 药品评价和研究中心(Center for Drug Evaluation and Research)
- In 2006, Brenda was the Acting Branch Chief in charge of the Biotech Manufacturing Branch in CDER.
2006年,她以分部执行主管的身份,负责了CDER生物技术生产部门的工作。 - Brenda started her FDA career as a CMC reviewer in CDER focusing on sterility assurance and the microbiological aspect of NDA, ANDA and BLA submissions.
她以CDER的CMC检查员职务开始了在FDA的职业生涯,关注无菌保障及NDA,ANDA以及BLA提交的微生物案例等。 - Parameters typically used in system suitability evaluations are defined and discussed in the CDER reviewer guidance on Validation of Chromatographic Methods (November 1994).
CDER评审官指南<<色谱分析方法的验证>>(1994年11月)对用于评估系统适应性的典型参数进行了定义和讨论。