Evaluation of Multiple Linear Regression Limited Sampling Strategies for Enteric-Coated Mycophenolate Sodium in Adult Kidney Transplant Recipients

Although multiple linear regression-based limited sampling strategies (LSS) have been published for enteric-coated mycophenolate sodium (EC-MS), none have been evaluated for the prediction of subsequent mycophenolic acid (MPA) exposure. This study aimed to examine the predictive performance of the published LSS for the estimation of future MPA area under the concentration-time curve from 0 to 12 hours (AUC0-12) in renal transplant recipients.Total MPA plasma concentrations were measured in twenty adult renal transplant patients on two occasions a week apart. All subjects received concomitant tacrolimus and were approximately one-month post transplant. Samples were taken at 0, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours and 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 9, and 12 hours post dose on the first and second sampling occasion, respectively. Predicted MPA AUC0-12 was calculated using nineteen published LSS and data from the first or second sampling occasion for each patient and compared to the second occasion full MPA AUC0-12 calculated using the linear trapezoidal rule. Bias (median percentage prediction error [MPPE]) and imprecision (median absolute prediction error [MAPE]) were determined.MPPE and MAPE for the prediction of full MPA AUC0-12 wer