title: Study design and implementation for population pharmacokinetics of Chinese medicine: An expert consensus.
abstract: Although many population pharmacokinetics (PPK) researches have been conducted on chemical drugs, few have been in the field of Chinese medicine (CM). Each ingredient in CMs possesses different pharmacokinetic characteristics, therefore, it is important to develop methods of PPK studies on them to identify the differences in CM drug safety and efficacy among the population subgroups and to conduct quantitative studies on the determinants of CM drug concentrations. To develop an expert consensus on study design and implementation for PPK of CM, in August 2013, 6 experts in the field of PPK, CMs pharmacology, and statistics discussed problems on the PPK research protocol of CMs, and a consensus was reached. The medicines with toxicity and narrow therapeutic windows and with wide range of target population or with frequent adverse reactions were selected. The compositions with definite therapeutic effects were selected as indices, and specific time points and sample sizes were designed according to standard PPK design methods. Target components were tested through various chromatography methods. Total quantity statistical moment analysis was used to estimate PPK parameters of each component and PPK models reflecting the trend of CMs (which assists in reasonable adjustments on clinical dosage). This consensus specifies the study design and implementation process of PPK. It provides guidance for the following: post-marketing clinical studies, in vivo investigations related to the metabolism in different populations, and development and clinical adjustment of dosages of CMs.
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
authors.forename: Jun-jie
authors.initials: JJ
authors.lastname: Jiang
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
authors.forename: Wen
authors.initials: W
authors.lastname: Zhang
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China. dataming5288@163.com.
authors.forename: Yan-ming
authors.initials: YM
authors.lastname: Xie
authors.affiliation: Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
authors.forename: Jian-nong
authors.initials: JN
authors.lastname: Wang
authors.affiliation: Hunan University of Chinese Medicine, Changsha, 410208, China.
authors.forename: Fu-yuan
authors.initials: FY
authors.lastname: He
authors.affiliation: Peking University Third Hospital, Beijing, 100191, China.
authors.forename: Xin
authors.initials: X
authors.lastname: Xiong
mesh_terms: D032921:Consensus; D004365:Drugs, Chinese Herbal / Q000493:pharmacokinetics*; D005104:Expert Testimony; D006801:Humans; D015233:Models, Statistical; D012107:Research Design
chemical_list: D004365:Drugs, Chinese Herbal
keywords: Chinese medicine; expert consensus; population pharmacokinetics; research protocol