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1 .国家食品药品监督管理局技术评价指导原则.抗肿瘤药物临床试验技术指导原则. http：/ / www . sfda . gov，2008.Center for drug evaluation and research package for application number 21-938：clinical pharmacology and biopharmaceutic review . http：/ / www . fda . gov/cder/foi/nda / 2006/021938 _ S ......