For TAC therapy, covariate models using mixed effects methods are most useful when combined with patient-specific biochemical assays as well as clinical evidence. In such cases, the observed C(min) and Bayes methods can provide the most likely individual PK parameters, hence the optimal next dose to reach individualized target levels for each patient.
Ten years of use of TAC shows gain in therapeutic targeting efficiency, due to improvement in LT methods, knowledge of the drug and consideration of PK steady state. The remaining uncertainty with TAC monitoring in LT can be resolved with application of PK principles combined with patients' diosyncrasies in the model developed for TAC dose individualization in R-1998. The applicability of the model as nucleus in Bayes individualization remains intact across a decade.
Purpose To explore the main factors that make difficult the empirical monitoring of Tacrolimus (TAC) in the early period post liver transplantation (LTx). Specifically, those aspects were stressed related with patient idiosyncrasy and clinical status and also those pharmacokinetic (PK) assumptions on which drug individualization is based in clinical practice.Methods Retrospective monitoring data from 75 de novo liver transplant patients treated with twice daily TAC and followed for up to 15 days were analyzed. Extensive laboratory measures were available. Dose adjustment was done empirically using trough levels (C min ). The population was separated into two background subgroups for low or high values of AST, Group 1 and Group 2, respectively. Data during the
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