title: Estimation of Abbreviated Cyclosporine A Area under the Concentration-Time Curve in Allogenic Stem Cell Transplantation after Oral Administration.
abstract: Measurements of Cyclosporine (CsA) systemic exposure permit its dose adjustment in allogenic stem cell transplantation recipients to prevent graft-versus-host disease. CsA LSSs were developed and validated from 60 ASCT patients via multiple linear regressions. All whole-blood samples were analyzed by fluorescence polarization immunoassay (FPIA-Axym). The 10 models that have used CsA concentrations at a single time point did not have a good fit with AUC(0-12) (R(2) < 0.90). C(2) and C(4) were the time points that correlated best with AUC(0-12 h), R(2) were respectively 0.848, and 0.897. The LSS equation with the best predictive performance (bias, precision and number of samples) utilized three sampling concentrations was AUC(0-12 h) = 0.607 + 1.569 × C(0.5) + 2.098 × C(2) + 3.603 × C(4) (R(2) = 0.943). Optimal LSSs equations which limited to those utilizing three timed concentrations taken within 4 hours post-dose developed from ASCT recipient's patients yielded a low bias <5% ranged from 1.27% to 2.68% and good precision <15% ranged from 9.60% and 11.02%. We propose an LSS model with equation AUC(0-12 h) = 0.82 + 2.766 × C(2) + 3.409 × C(4) for a practical reason. Bias and precision for this model are respectively 2.68% and 11.02%.
authors: Laboratoire de Pharmacologie Clinique, Centre National de Pharmacovigilance, 9 Avenue Dr. Zouheïr Essafi, Tunis 1006, Tunisia.
authors: Hanene
authors: H
authors: Eljebari
authors: Nadia
authors: N
authors: Ben Fradj
authors: Issam
authors: I
authors: Salouage
authors: Emna
authors: E
authors: Gaies
authors: Sameh
authors: S
authors: Trabelsi
authors: Nadia
authors: N
authors: Jebabli
authors: Mohamed
authors: M
authors: Lakhal
authors: Tarek
authors: T
authors: Ben Othman
authors: Anis
authors: A
authors: Kouz