Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency
美国食品药品监督管理局和欧洲药品管理局在药品上市申请良好临床规范检查流程方面的比较
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doi:10.1007/s43441-022-00441-w
Ayalew, Kassa; Ning, Yang-Min; Foringer, Michelle J; Leibenhaut, Susan; Sellers, Jenn W; Yu, Bei; Kronstein, Phillip D; Higgerson, Agata; Mihaescu, Camelia; Rodriguez, Miguel; Williams, LaKisha; Khin, Ni A
