8Department of Health and Human Services, U. S. Food and Drug Adminis- tration. Pharmaceutical cGMPs for the 21st Century-A Risk-Based Approach: FinalReport-Fall 2004 [EB/OL. [2004)9]. http://www, fda. gov/ drugs/developmentapprovalprocess/manufacturing/qnestionsandanswersoncur- pfordrugs/ucm137175, htm.
10ZHU FC, ZHANG J, ZHANG XF, et al. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial [ J]. Lancet, 2010, 376(9744): 895-902.
