Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA
Huang, F.
Zhongguo Zhong Yao Za Zhi 35(7): 932-935
2010
ISSN/ISBN: 1001-5302 PMID: 20575403 Document Number: 643187
Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine.