External Validation of a Limited Sampling Strategy for the Estimation of Mycophenolic Acid Exposure Between Different Assay Methods: PETINIA and HPLC Methods
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Abstract
Introduction
A limited sampling strategy (LSS) for estimating the area under the plasma concentration–time curve (AUC0–12) of the immunosuppressant mycophenolic acid (MPA) is used for therapeutic drug monitoring (TDM) in clinical practice. Our study delves into the applicability of the MPA AUC0–12 LSS, originally developed using particle-enhanced turbidimetric inhibition immunoassay (PETINIA) measurements, to those obtained via high-performance liquid chromatography with ultraviolet detection (HPLC–UV).
Methods
We developed an LSS for estimating MPA AUC0–12 based on PETINIA measurements in 32 adult kidney transplant patients who were receiving mycophenolate mofetil. Validation of this strategy was conducted in an additional 14 adult kidney transplant patients (validation sets) through measurements obtained by both PETINIA and HPLC–UV. Predictive performance was assessed using mean absolute error (MAE), root mean squared error (RMSE), and “good guess” defined as predicted AUC within observed AUC ± 15%.
Results
The three time point equation (0, 2, and 6 h) emerged as optimal for estimating MPA AUC0–12, balancing predictive performance and usefulness in clinical settings. In validation sets, the coefficient of determination for observed versus predicted AUC0–12 was consistent between PETINIA (0.978) and HPLC–UV (0.958) measurements. Comparable MAE, RMSE, and “good guess” outcomes were observed for PETINIA (6.4%, 8.1%, and 85.7%, respectively) and HPLC–UV (7.6%, 9.4%, and 85.7%, respectively) measurements.
Conclusion
Our findings support the application of the MPA AUC0–12 LSS, originally developed using PETINIA measurements, to those obtained via HPLC–UV.
期刊介绍:
Clinical Transplantation: The Journal of Clinical and Translational Research aims to serve as a channel of rapid communication for all those involved in the care of patients who require, or have had, organ or tissue transplants, including: kidney, intestine, liver, pancreas, islets, heart, heart valves, lung, bone marrow, cornea, skin, bone, and cartilage, viable or stored.
Published monthly, Clinical Transplantation’s scope is focused on the complete spectrum of present transplant therapies, as well as also those that are experimental or may become possible in future. Topics include:
Immunology and immunosuppression;
Patient preparation;
Social, ethical, and psychological issues;
Complications, short- and long-term results;
Artificial organs;
Donation and preservation of organ and tissue;
Translational studies;
Advances in tissue typing;
Updates on transplant pathology;.
Clinical and translational studies are particularly welcome, as well as focused reviews. Full-length papers and short communications are invited. Clinical reviews are encouraged, as well as seminal papers in basic science which might lead to immediate clinical application. Prominence is regularly given to the results of cooperative surveys conducted by the organ and tissue transplant registries.
Clinical Transplantation: The Journal of Clinical and Translational Research is essential reading for clinicians and researchers in the diverse field of transplantation: surgeons; clinical immunologists; cryobiologists; hematologists; gastroenterologists; hepatologists; pulmonologists; nephrologists; cardiologists; and endocrinologists. It will also be of interest to sociologists, psychologists, research workers, and to all health professionals whose combined efforts will improve the prognosis of transplant recipients.