Our data indicate that elderly renal transplant recipients starting EVL 1 month after transplantation along with a steady-state TCL level, present stable EVL-PK parameters without significant changes in dose or exposure during the first 6 months after renal transplantation.

These data show that the pharmacokinetics of MPA in elderly renal transplant recipients were no different to those of younger-adult recipients in this study population. CLINICALTRIALS.GOV: NCT 01631058.

Introduction: This paper presents the failure modes and effects analysis (FMEA) tool in a clinical laboratory through the introduction of new technology for blood gas and serum ionized calcium in multi-parameter analyzers such as Point of Care Testing (POCT). Objective: To present FMEA as a tool for risk managing and improvement with the introduction of new technologies in a public laboratory. Methods: The change of multiparameter gas analyzer type POCT was defined and described as a process. Subsequently, the criteria were presented to the risk assessment and its quantification. We studied the failure modes that might occur in this process. We established three action plans involving improvements to be made in the technological change. FMEA was applied in two stages: at the beginning of the project and after the implementation of the proposed measures. Results: The first plan involved administrative measures related to the bidding process; the second preventive action involved the possibility of which supplier would win the bid by studying the efficiency of the analyzer and its impact on productivity; the third set of actions was directed to improvements in the relationship with the clinical staff in order to minimize occasional complaints. The last actions referred to employing new employees to meet the growing demand. Conclusion: FMEA proved to be a reliable tool for performance improvement, which proactively identifies, prioritizes and mitigates patient risks.

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Aims: To validate an SPE-ultra-HPLC-MS/MS method for thalidomide (THD) measurement in dried plasma spot (DPS). Methods: Extraction included acetonitrile/water clean-up and online SPE. The LOD, LLOQ, linearity, precision, accuracy, recovery, matrix effect, process efficiency, carryover, stability, drug interference and dilution integrity were assessed. Results: The method was linear from 50 to 2000 ng/ml with a LOD of 20 ng/ml and LLOQ of 50 ng/ml. The coefficient of variation for precision was 0.4–7.9% for intra-assay and 1.3–8.9% for interassay and accuracy was 81.4–97.1%. Adequate matrix effect (100.6–107.0%), recovery (88.7–105.0%) and process efficiency (91.3–109.3%) were registered. DPS was stable for 14 days at room temperature and 45°C and for 4 months at -80°C. The method was applied to quantify THD in both wet plasma and DPS from patients with cutaneous lupus receiving THD treatment. The difference between THD wet plasma and DPS concentration was <15%. Conclusion: The method is suitable to quantify THD in DPS.