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  5. MRCTs for China Submission-Practice,Challenge and Future direction

MRCTs for China Submission-Practice,Challenge and Future direction

来源 :上海交通大学 | 被引量 : 0次 | 上传用户：tszl8
【摘 要】
：
Global submission with data from MRCTs is a normal practice,particularly for big outcome studies,rare disease,or disease with high unmet medical need etc.
【作 者】
：
Sherry Zhao 
【机 构】
：
Beijing Novartis Pharma Co.,Ltd,201203,China
【出 处】
：
上海交通大学
【发表日期】
：
2016年4期
【关键词】
：
MRCT global drug development NDA submission in China 
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　　Global submission with data from MRCTs is a normal practice,particularly for big outcome studies,rare disease,or disease with high unmet medical need etc.
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