title: [Phase 0 clinical trials and post-marketed re-evaluation of clinical safety in injection of traditional Chinese medicine].
abstract: Adverse drug reaction induced by injection of traditional Chinese medicine(TCM) often occurs. Post-marketed re-evaluation of clinical safety in injection of TCM is indispensable,in order to solve the clinical safety problems. It is necessary to conduct Phase 0 clinical trials for containing toxic medicine and injection of TCM. Phase 0 clinical trials, involving very limited human exposure, and using microdose of drugs, are intended to collect the necessary safety and pharmacokinetic data in limited period. Microdose reflects allergies of injection of TCM. Phase 0 clinical trials provide a new method for post-marketed re-evaluation of safety in injection of TCM. Its use depends on whether there is a safety problem for injection of TCM,and the determination of initial dose and sample size are key questions in study design.
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. weixu.007@163.com
authors.forename: Xu
authors.initials: X
authors.lastname: Wei
authors.forename: Zhanjun
authors.initials: Z
authors.lastname: Zhang
authors.forename: Yanming
authors.initials: Y
authors.lastname: Xie
authors.forename: Yongyan
authors.initials: Y
authors.lastname: Wang
mesh_terms: D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007267:Injections; D008516:Medicine, Chinese Traditional / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing