期刊
EXPERT REVIEW OF VACCINES
卷 8, 期 2, 页码 227-238出版社
TAYLOR & FRANCIS LTD
DOI: 10.1586/14760584.8.2.227
关键词
animal model; clinical trial; correlates of protection; physicochemical and immunochemical technique; process development; quality control; vaccine development
类别
The successful development of vaccines is a lengthy process, requiring input from different expertises, such as research and development, quality control, quality assurance, production, regulatory affairs, and marketing and sales. A cornerstone in vaccine development is the availability of a panel of high-quality assays that can reduce the risk of failure in clinical trials and licensure. This review highlights the quality-control issues and approaches in vaccine development from different viewpoints: discovery, process development, assay development, clinical development and the postlicensing phase.
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