[Characteristics and difficulties in clinical trials of new traditional Chinese drugs].
Therapeutic efficacy is the point of starting and ending for research and developing of new traditional Chinese drugs, and clinical trials could provide a good platform for its efficacy evaluation. The characteristics of Chinese patent medicine is clarified in this paper by comparing its difference from Chinese herbal decoction, and the characteristics and difficulties in clinical trials for developing Chinese new drugs were also probed in referrence to the present situation and progress of the concerning topics.
Wang
Hai-nan
HN
Center for Drug Evaluation, State Food and Drug Administration, Beijing. md.wanghainan@yahoo.com.cn
D002986:Clinical Trials as Topic; D003937:Diagnosis, Differential; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D015507:Drugs, Investigational / Q000627:therapeutic use*; D006801:Humans; D008516:Medicine, Chinese Traditional
D004365:Drugs, Chinese Herbal; D015507:Drugs, Investigational