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[Population pharmacokinetics of tacrolimus in Chinese renal transplant patients].
Yao Xue Xue Bao. 2008 Jul; 43(7):695-701.YX

Abstract

The goal of this study is to investigate the population pharmacokinetics of oral tacrolimus in Chinese renal transplant patients and to identify possible relationship between covariates and population parameters. Details of drug dosage history, sampling time and concentration of 802 data points in 58 patients were collected retrospectively. Before analysis, the 58 patients were randomly allocated to either the model building group (n=41) or the validation group (n=17). Population pharmacokinetic data analysis was performed using the nonlinear mixed-effects model (NONMEM) program on the model building group. The pharmacokinetics of tacrolimus was best described by a one compartment model with first-order absorption and elimination. Typical values of apparent clearance (CL/F), apparent volume of distribution (V/F) were estimated. A number of covariates including demographic index, clinical index and coadministration of other drugs were evaluated statistically for their influence on these parameters. The final population model related clearance with POD (post operative days), HCT (haematocrit), AST (aspartate aminotransferase) and coadministration of nicardipine and diltiazem. Predictive performance of the final model evaluated with the validation group showed insignificant bias between observed and model predicted concentrations. Typical value of CL/F and V/F was 21.7 L x h(-1) and 241 L, inter-patient variability (RSD) in CL/F and V/F was 41.6% and 49.7%, respectively. The residual variability (SD) between observed and model-predicted concentrations was 2.19 microg x L(-1). The population pharmacokinetic model of tacrolimus in Chinese renal transplant patients was established and significant covariates on the tacrolimus model were identified.

Authors+Show Affiliations

School of Pharmaceutical Science, Peking University, Beliing 100083, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

English Abstract
Journal Article
Randomized Controlled Trial

Language

chi

PubMed ID

18819472

Citation

Zhang, Guan-min, et al. "[Population Pharmacokinetics of Tacrolimus in Chinese Renal Transplant Patients]." Yao Xue Xue Bao = Acta Pharmaceutica Sinica, vol. 43, no. 7, 2008, pp. 695-701.
Zhang GM, Li L, Chen WQ, et al. [Population pharmacokinetics of tacrolimus in Chinese renal transplant patients]. Yao Xue Xue Bao. 2008;43(7):695-701.
Zhang, G. M., Li, L., Chen, W. Q., Bi, S. S., Liu, X., Zhang, X. L., & Lu, W. (2008). [Population pharmacokinetics of tacrolimus in Chinese renal transplant patients]. Yao Xue Xue Bao = Acta Pharmaceutica Sinica, 43(7), 695-701.
Zhang GM, et al. [Population Pharmacokinetics of Tacrolimus in Chinese Renal Transplant Patients]. Yao Xue Xue Bao. 2008;43(7):695-701. PubMed PMID: 18819472.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Population pharmacokinetics of tacrolimus in Chinese renal transplant patients]. AU - Zhang,Guan-min, AU - Li,Liang, AU - Chen,Wen-qian, AU - Bi,Shan-shan, AU - Liu,Xiao, AU - Zhang,Xiang-lin, AU - Lu,Wei, PY - 2008/9/30/pubmed PY - 2009/9/18/medline PY - 2008/9/30/entrez SP - 695 EP - 701 JF - Yao xue xue bao = Acta pharmaceutica Sinica JO - Yao Xue Xue Bao VL - 43 IS - 7 N2 - The goal of this study is to investigate the population pharmacokinetics of oral tacrolimus in Chinese renal transplant patients and to identify possible relationship between covariates and population parameters. Details of drug dosage history, sampling time and concentration of 802 data points in 58 patients were collected retrospectively. Before analysis, the 58 patients were randomly allocated to either the model building group (n=41) or the validation group (n=17). Population pharmacokinetic data analysis was performed using the nonlinear mixed-effects model (NONMEM) program on the model building group. The pharmacokinetics of tacrolimus was best described by a one compartment model with first-order absorption and elimination. Typical values of apparent clearance (CL/F), apparent volume of distribution (V/F) were estimated. A number of covariates including demographic index, clinical index and coadministration of other drugs were evaluated statistically for their influence on these parameters. The final population model related clearance with POD (post operative days), HCT (haematocrit), AST (aspartate aminotransferase) and coadministration of nicardipine and diltiazem. Predictive performance of the final model evaluated with the validation group showed insignificant bias between observed and model predicted concentrations. Typical value of CL/F and V/F was 21.7 L x h(-1) and 241 L, inter-patient variability (RSD) in CL/F and V/F was 41.6% and 49.7%, respectively. The residual variability (SD) between observed and model-predicted concentrations was 2.19 microg x L(-1). The population pharmacokinetic model of tacrolimus in Chinese renal transplant patients was established and significant covariates on the tacrolimus model were identified. SN - 0513-4870 UR - https://www.unboundmedicine.com/medline/citation/18819472/[Population_pharmacokinetics_of_tacrolimus_in_Chinese_renal_transplant_patients]_ L2 - https://medlineplus.gov/kidneytransplantation.html DB - PRIME DP - Unbound Medicine ER -