A Limited Sampling Method for the Estimation of Vigabatrin Maximum Plasma Concentration and Area Under the Curve

摘要

A limited sampling model (LSM) was developed to estimate the area under the curve (AUC) and maximum plasma concentration (Cmax) for a 1-g oral dose of vigabatrin. The model was developed using the data from 10 healthy subjects and one time point. The following equations describe the model for AUC andCmax: AUC(predicted)= 5.4 times;C3h+ 70 andCmax(predicted)= 0. 18 times; AUC(O-infinity)+ 9.4. The model was validated in 49 subjects who orally received 1-g vigabatrin. This LSM was also used to predict AUC andCmaxvolunteers who received 2- and 4-g vigabatrin doses and in renal failure patients who were given a 0.75-g dose. The model provided good estimates of both AUC andCmaxin all groups of subjects except renal dysfunction patients. The method described here may be used to estimate AUC andCmaxof vigabatrin without detailed pharmacokinetic studies.