Tag Archives: Christine Moore

FDA对药品开发行业质量源于设计的观点

在过去的五年里, FDA和ICH质量倡导在药品研发与生产行业开启了一个跳跃性转变。在第十七届工艺过程开发国际会议上,Christine Moore作了一个关于FDA对药品开发行业质量源于设计(QbD)的观点的报告。在她的报告中, Christine谈到美国食品药品管理局(FDA)相信质量源于设计提供的各种优势,包括: Continue reading

FDA Perspective on Quality by Design (QbD) in Pharmaceutical Development

Over the last five years, FDA and ICH quality initiatives created a paradigm shift in pharmaceutical discovery, development, and manufacturing.  At the 17th International Process Development Conference, Christine Moore gave a presentation on the FDA perspective on Quality by Design (QbD) in pharmaceutical development.  During her presentation, Christine discussed the advantages that the U.S. Food and Drug Administration (FDA) believes Quality by Design offers, including: Continue reading