Limited sampling strategy models for estimating the AUC of gliclazide in Chinese healthy volunteers.
The aim of this work is to reduce the cost of required sampling for the estimation of the area under the gliclazide plasma concentration versus time curve within 60 h (AUC0-60t ). The limited sampling strategy (LSS) models were established and validated by the multiple regression model within 4 or fewer gliclazide concentration values. Absolute prediction error (APE), root of mean square error (RMSE) and visual prediction check were used as criterion. The results of Jack-Knife validation showed that 10 (25.0 %) of the 40 LSS based on the regression analysis were not within an APE of 15 % using one concentration-time point. 90.2, 91.5 and 92.4 % of the 40 LSS models were capable of prediction using 2, 3 and 4 points, respectively. Limited sampling strategies were developed and validated for estimating AUC0-60t of gliclazide. This study indicates that the implementation of an 80 mg dosage regimen enabled accurate predictions of AUC0-60t by the LSS model. This study shows that 12, 6, 4, 2 h after administration are the key sampling times. The combination of (12, 2 h), (12, 8, 2 h) or (12, 8, 4, 2 h) can be chosen as sampling hours for predicting AUC0-60t in practical application according to requirement.
Department of Pharmacometrics, Center for Drug Clinical Research, Shanghai University of Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.
Ji-Han
JH
Huang
Kun
K
Wang
Xiao-Hui
XH
Huang
Ying-Chun
YC
He
Lu-Jin
LJ
Li
Yu-Cheng
YC
Sheng
Juan
J
Yang
Qing-Shan
QS
Zheng
D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D005907:Gliclazide / Q000493:pharmacokinetics*; D006801:Humans; D007004:Hypoglycemic Agents / Q000493:pharmacokinetics*; D008297:Male; D012044:Regression Analysis; D013810:Therapeutic Equivalency; D055815:Young Adult
D007004:Hypoglycemic Agents; D005907:Gliclazide