Study design and implementation for population pharmacokinetics of Chinese medicine: An expert consensus
详细信息 查看全文
- 作者：Jun-jie Jiang 姜俊替/a> ; Wen Zhang 庿陿/a>…
- 关键词：population pharmacokinetics ; expert consensus ; research protocol ; Chinese medicine
- 刊名：Chinese Journal of Integrative Medicine
- 出版年：2016
- 出版时间：February 2016
- 年：2016
- 卷：22
- 期：2
- 页码：154-160
- 全文大小：163 KB
- 参考文献：1.The Food and Drug Administration. Guidance for industry. Population pharmacokinetics. 1999. Available from: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM072137.pdf
2.Technical Guidance Study Group. Technical guidance for pharmacokinetics of chemical drugs code. 2005. Available from: http://www.acec.gov.cn/info/info/2009224834320.pdf
3.Peng L, Gao XY, Guo MX, Su JK. Researching ideas of traditional Chinese medicine pharmacokinetics. The fifth academic conference proceedings of Specialty Committee of Analysis of Chinese Medicine. China Assoc Chin Med (Chin) 2012;209–212.
4.Zhao YN, Xing DM, Ding Y, Pan WS, Wang W, Cheng J, et al. Pharmacokinetic study on the antipyretic compound YL2000. Chin Pharmacol Bullet (Chin) 2004;20:776–780.
5.Liu HF, Yang JL, Du FF, Gao XM, Ma XT, Huang YH, et al. Absorption and disposition of ginsenosides after oral administration of Panax notoginseng extract to rats. Drug Metab Dispos 2009;37:2290–2298.CrossRef PubMed
6.The Food and Drug Administration. Guidance for industry bioanalytical method validation. 2001. Available from: www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368107.pdf .
7.He FY, Deng KW, Liu WL, Shi JL, Yang YT. Population pharmacokinetics of multiple-ingredient system of compound chinese medicines: mathematic model for total quantum statistical moment and parameter calculation study. China J Chin Mater Med (Chin) 2011;36:2866–2870. - 作者单位：Jun-jie Jiang 姜俊杰 (1)
Wen Zhang 张 雯 (1)
Yan-ming Xie 谢雁鸣 (1)
Jian-nong Wang 王建农 (2)
Fu-yuan He 贺福元 (3)
Xin Xiong 熊 歆 (4)
1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China
2. Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China
3. Hunan University of Chinese Medicine, Changsha, 410208, China
4. Peking University Third Hospital, Beijing, 100191, China - 刊物主题：Medicine/Public Health, general;
- 出版者：Springer Berlin Heidelberg
- ISSN：1993-0402
文摘
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.