![]() However it has quickly become famous as a celebrity slimming. QC programs are crucial to monitoring and maintaining the quality of an analytical method. Ozempic, which contains the active ingredient semaglutide, is licensed for managing blood sugar levels in people with type 2 diabetes. We conclude that TDM is an effective method of achieving targeted Bu levels in children. Storage at -80☌ led to a fall in Bu content of 14.9% ± 13.4% at 2-4 years and of 20% ± 5% by 5 years (roverall = 0.92). Two of the 21 Bu TDM centers returned inadequate results during cross-validation testing both used a UV detection method. Routine QC measurements were generally within the ☑5% range around theoretical values, showing the optimal robustness of our center's analytical method. This achieved a Css within the target range in 75% of the children. Therapeutic Drug Monitoring of Busulfan for the Management of Pediatric Patients: Cross-Validation of Methods and Long-Term Performance. During the 4 days of conditioning, 83% of children had their doses modified according to TDM recommendations. We observed a 4.2-fold interindividual variability in Bu Css after the first dose, with only 28% of children having a Css within the target range. To assess Bu stability, regression analyses and Bland-Altman plots were performed on measurements at repeated time points on samples stored at -80☌ for up to 5 years. International, multicenter, cross-validation test (n = 21) was conducted to validate different analytical methods. The performance of our unit's high-performance liquid chromatography with tandem mass spectrometry method was assessed using a quality control (QC, 35 series) chart. The first dose of Bu was age/weight-based, and the subsequent doses were adjusted from third or fifth dose onward based on the estimated first dose pharmacokinetic parameters to target steady-state concentrations (Css) of 600-900 ng/mL. All of them received a 2-hour Bu IV infusion 4 times daily for a total of 16 doses. We aimed to assess the utility of therapeutic drug monitoring (TDM) of Bu in children, the reliability of Bu quantification methods, and its stability in plasma when stored for up to 5 years.Įighteen patients from our TDM center (252 samples) were included. In this context, adjusting doses to Bu's narrow therapeutic window is advised. ![]() Despite intravenous (IV) administration and dosing recommendations based on age and weight, reports have revealed interindividual variability in Bu pharmacokinetics and the outcomes of hematopoietic stem cell transplantation. Busulfan (Bu) is an alkylating agent used as part of the conditioning regimen in pediatric patients before hematopoietic stem cell transplantation. ![]()
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