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Zhongguo Zhong Xi Yi Jie He Za Zhi. 2009 Nov;29(11):1035-9.

[Consideration about data management and biostatistics analysis from a FDA's botanical drug approval case].

[Article in Chinese]

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Center for Drug Evaluation, State Food and Drug Administration, Beijing.


FDA approved the first botanical drug of non-simplex ingredient on 31st Oct 2006. The new drug's trade name is Veregen 15% Ointment. Veregen succeeded in coming into the market in U.S, which attracts other countries and regions' attention where traditional herbs have been always used. From the viewpoints of data management and biostatistics method, the authors will think and discuss this case well, and hope to promote domestic new drug investigation.

[Indexed for MEDLINE]
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