[Discussion about relativity between post-marketed safety outcome and treatment course of traditional Chinese medicine drugs on basis of reinforced urn processes].
Based on relevant research and development, the possibility of applying the reinforced urn processes (RUPs) statistical approach to traditional Chinese medicine(TCM) drugs safety research is discussed in this paper, primarily through theoretical discussion and simulations. Also introduced are work flows and the key points for the application of the RUPs approach. This potentially new approach has recently been applied to the target estimation of phase I human tolerance clinical trials. A traditional RUPs approach has also been widely applied in the precise point-estimation of allowable longest treatment courses, according to the particular safety outcomes of post-marketed TCM.
GCP Center, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China. clitripro@sina.com.cn
Cheng-Liang
CL
Zhong
GCP Center, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
Si-Yuan
SY
Hu
GCP Center, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
Yan-Ming
YM
Xie
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Yong-Yan
YY
Wang
D004358:Drug Therapy; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D011358:Product Surveillance, Postmarketing; D012044:Regression Analysis; D016896:Treatment Outcome
D004365:Drugs, Chinese Herbal