Limited sampling strategy models for estimating the AUC of gliclazide in Chinese healthy volunteers

• Published in: European journal of drug metabolism and pharmacokinetics Vol. 38; no. 2; pp. 123 - 130
• Main Authors: Huang, Ji-Han, Wang, Kun, Huang, Xiao-Hui, He, Ying-Chun, Li, Lu-Jin, Sheng, Yu-Cheng, Yang, Juan, Zheng, Qing-Shan
• Format: Journal Article
• Language: English
• Published: Paris Springer-Verlag 01.06.2013
• Subjects: Adolescent; Adult; Area Under Curve; Biomedical and Life Sciences; Biomedicine; Gliclazide - pharmacokinetics; Human Physiology; Humans; Hypoglycemic Agents - pharmacokinetics; Male; Medical Biochemistry; Original Paper; Pharmaceutical Sciences/Technology; Pharmacology/Toxicology; Pharmacy; Regression Analysis; Therapeutic Equivalency; Young Adult; Gliclazide; Jack-Knife; Bootstrap; Limited sampling strategy; AUC
• ISSN: 0378-7966; 2107-0180
• DOI: 10.1007/s13318-012-0096-7

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 (AUC 0−60 t ). 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 AUC 0−60 t of gliclazide. This study indicates that the implementation of an 80 mg dosage regimen enabled accurate predictions of AUC 0−60 t 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 AUC 0−60 t in practical application according to requirement.