Consideration about data management and biostatistics analysis from a FDA's botanical drug approval case / 中国中西医结合杂志
Chinese Journal of Integrated Traditional and Western Medicine
;
(12): 1035-1039, 2009.
Article
in Chinese
| WPRIM
| ID: wpr-242320
ABSTRACT
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Research Design
/
United States
/
United States Food and Drug Administration
/
Pharmaceutical Preparations
/
Biostatistics
/
Drug Approval
/
Plant Preparations
Country/Region as subject:
North America
Language:
Chinese
Journal:
Chinese Journal of Integrated Traditional and Western Medicine
Year:
2009
Type:
Article
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