A LIMITED SAMPLING METHOD FOR THE ESTIMATION OF VIGABATRIN MAXIMUM PLASMA-CONCENTRATION AND AREA-UNDER-THE-CURVE

A limited sampling model (LSM) was developed to estimate the area unde r the curve (AUC) and maximum plasma concentration (C-max) for a 1-g o ral 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 and C-max: AUC((predicted)) = 5.4 x C-3h + 70 and C -max(predicted) = 0.18 x AUC((0-infinity)) + 9.4. The model was valida ted in 49 subjects who orally received 1-g vigabatrin. This LSM was al so used to predict AUC and C-max volunteers who received 2- and 4-g vi gabatrin doses and in renal failure patients who were given a 0.75-g d ose. The model provided good estimates of both AUC and C-max in all gr oups of subjects except renal dysfunction patients. The method describ ed here may be used to estimate AUC and C-max of vigabatrin without de tailed pharmacokinetic studies.