中国上市的首个first in class新药欧美何时批准?罗沙司他最新心血管安全性结果分析(4)
2019-06-13 未知 admin
参考资料
[1] FibroGen Announces Positive Topline Results from Pooled Safety Analyses of Roxadustat Global Phase 3 Program:http://phx.corporate-ir.net/phoenix.zhtml?c=253783&p=irol-newsArticle&ID=2398154
[2] Guidancefor Industry Diabetes Mellitus — Evaluating Cardiovascular Risk in NewAntidiabetic Therapies to Treat Type 2 Diabetes:https://www.fda.gov/media/71297/download
[3] https://www.nejm.org/doi/full/10.1056/NEJMoa1611593
[4] Poolingclinical data:keypoints and pitfalls:https://lexjansen.com/phuse/2012/dh/DH01.pdf
[5] FDA相关药物的医学审评报告
*声明:本文由入驻新浪医药新闻作者撰写,观点仅代表作者本人,不代表新浪医药新闻立场。
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