Study Design and Implementation for Population Pharmacokinetics of Chinese Medicine：An Expert Consensus

• Published in: Chinese journal of integrative medicine Vol. 22; no. 2; pp. 154 - 160
• Main Author: 姜俊杰 张雯 谢雁鸣 王建农 贺福元 熊歆
• Format: Journal Article
• Language: English
• Published: Beijing Chinese Association of Traditional and Western Medicine 01.02.2016
• Subjects: Consensus; Drugs, Chinese Herbal - pharmacokinetics; Expert Testimony; Humans; Medicine; Medicine & Public Health; Models, Statistical; Regulation and Guideline; Research Design; 专家; 中国医学; 人群; 动力学特征; 化学药物; 合理调整; 药代动力学; 设计方法; Chinese medicine; expert consensus; research protocol; population pharmacokinetics
• ISSN: 1672-0415; 1993-0402; 1993-0402
• DOI: 10.1007/s11655-014-1995-z

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.