[Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA].
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.
Huang
Fanghua
F
Center for Drug Evaluation, State Food and Drug Administration, Beijing 100038, China. huangfh@cde.org.cn
D002392:Catechin / Q000031:analogs & derivatives* / Q000737:chemistry / Q000493:pharmacokinetics; D002626:Chemistry, Pharmaceutical; D017277:Drug Approval; D004365:Drugs, Chinese Herbal / Q000737:chemistry / Q000493:pharmacokinetics*; D008516:Medicine, Chinese Traditional; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
D004365:Drugs, Chinese Herbal; C527126:green tea extract polyphenone E; D002392:Catechin