Population pharmacokinetics of risperidone based on meta-analysis and its application in therapeutic drug monitoring of Chinese schizophrenic patients

doi:10.5246/jcps.2014.02.009

Journal of Chinese Pharmaceutical Sciences

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Population pharmacokinetics of risperidone based on meta-analysis and its application in therapeutic drug monitoring of Chinese schizophrenic patients

Shuangmin Ji, Dewei Shang, Xipei Wang, Anning Li, Yupeng Ren, Liang Li, Tianyan Zhou, Chuanyue Wang, Wei Lu^*

1. State Key Laboratory of Natural and Biomimetic Drugs, Peking University Health Science Center, Beijing 100191, China
2. School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing 100191, China
3. Institution of National Drug Clinical Trials of Guangzhou Psychiatric Hospital, Guangzhou 510370, China
4. Department of Clinical Pharmacology, Guangdong Cardiovascular Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510080, China
5. Beijing Anding Hospital, Capital Medical University, Beijing 100088, China

Received:2013-05-13 Revised:2013-05-27 Online:2014-02-15 Published:2014-01-25
Contact: Wei Lu*
About author:*Corresponding author. Tel.: 86-10-82801717; E-mail: luwei_pk@bjmu.edu.cn
Supported by:
Guangzhou Municipality Medical and Technology Project (Grant No. 20131A011087); Beijing Key Lab of Diagnostics and Therapeutics for Psychiatric disorders 2013 Open Foundation (Grant No. 2013JSJB01); Beijing Municipal Education Commission Science and Technology Development Program (Grant No. KM201110025025).

Abstract

Abstract:

Population pharmacokinetic meta-analysis method was used in order to obtain the pharmacokinetic characteristics of risperidone and its active metabolite. Eighteen studies were selected from published papers from 1995 to 2011. A model consisted of two compartments for parent drug and one compartment for its active metabolite combined with a flexible absorption process was developed based on the meta-dataset. The population-predicted apparent clearance for risperidone and 9-hydroxyrisperidone, the active metabolite was 7.66 L/h and 7.38 L/h, and the apparent volume of distribution in the central compartment was 70.6 L and 117 L, respectively. The final model was evaluated by visual predictive check (VPC) based on 1000 times model simulation. This model was adequately used to predict clinical therapeutic drug monitoring (TDM) data from 42 Chinese inpatients. Bias (mean prediction errors, MPE) and precision (root mean squared prediction errors, RMSE) were calculated to statistically analysis the population prediction error. It was demonstrated that the model developed from the meta-dataset was reliable and can be used to facilitate the individualized treatment for a target population.

Key words: Meta-analysis, Population pharmacokinetics, Risperidone, 9-Hydroxyrisperidone

Supporting:

Shuangmin Ji, Dewei Shang, Xipei Wang, Anning Li, Yupeng Ren, Liang Li, Tianyan Zhou, Chuanyue Wang, Wei Lu. Population pharmacokinetics of risperidone based on meta-analysis and its application in therapeutic drug monitoring of Chinese schizophrenic patients[J]. Journal of Chinese Pharmaceutical Sciences, DOI: 10.5246/jcps.2014.02.009.

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Population pharmacokinetics of risperidone based on meta-analysis and its application in therapeutic drug monitoring of Chinese schizophrenic patients

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