Consideration about data management and biostatistics analysis from a FDA's botanical drug approval case.
- Author:
Jian-yuan TANG
1
;
Fang-hua HUANG
;
Fei-peng ZHU
Author Information
1. Center for Drug Evaluation, State Food and Drug Administration, Beijing.
- Publication Type:Journal Article
- MeSH:
Biostatistics;
Drug Approval;
Pharmaceutical Preparations;
Plant Preparations;
Research Design;
statistics & numerical data;
United States;
United States Food and Drug Administration;
statistics & numerical data
- From:
Chinese Journal of Integrated Traditional and Western Medicine
2009;29(11):1035-1039
- CountryChina
- Language:Chinese
-
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.
