Trial reportClinical pharmacokinetics2006
Quantification of busulfan in saliva and plasma in haematopoietic stem cell transplantation in children : validation of liquid chromatography tandem mass spectrometry method.
Trial report in Clinical pharmacokinetics, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- A practical guide to therapeutic drug monitoring in busulfan: recommendations from the Pharmacist Committee of the European Society for Blood and Marrow Transplantation (EBMT).Bone marrow transplantation · 2024Guideline
- A descriptive systematic review of salivary therapeutic drug monitoring in neonates and infants.British journal of clinical pharmacology · 2018Pooled it
- Saliva as a noninvasive sampling matrix for therapeutic drug monitoring of intravenous busulfan in Chinese patients undergoing hematopoietic stem cell transplantation: A prospective population pharmacokinetic and simulation study.CPT: pharmacometrics & systems pharmacology · 2023Article
- Precision sirolimus dosing in children: The potential for model-informed dosing and novel drug monitoring.Frontiers in pharmacology · 2023Review
- Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children.Journal of clinical pharmacology · 2018Review
- Therapeutic salivary monitoring of IV busulfan in patients undergoing hematopoietic stem cell transplantation: a pilot study.Bone marrow transplantation · 2017Observational
- The Saliva Exposome for Monitoring of Individuals' Health Trajectories.Environmental health perspectives · 2017Article
- An LC-MS Assay with Isocratic Separation and On-line Solid Phase Extraction to Improve the Routine Therapeutic Drug Monitoring of Busulfan in Plasma.Journal of medical biochemistry · 2017Article
- Pharmacokinetic studies in infants using minimal-risk study designs.Current clinical pharmacology · 2014Review
- The role of population PK-PD modelling in paediatric clinical research.European journal of clinical pharmacology · 2011Review
- Intravenous busulfan: in the conditioning treatment of pediatric patients prior to hematopoietic stem cell transplantation.Paediatric drugs · 2007Article
Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveBusulfan pharmacokinetic studies suggest that an individual dosing strategy may be necessary to optimise systemic exposure in order to decrease toxicity and improve outcome in haematopoietic stem cell transplantation. Therapeutic and toxic effects of the busulfan/cyclophosphamide regimen have been related to the area under the busulfan plasma concentration-time curve. Because of practical limitations in obtaining blood from children, saliva was evaluated as an alternative matrix for therapeutic drug monitoring, offering the advantages of a non-invasive, rapid and easy sampling procedure. Another objective was to evaluate an easy and robust liquid chromatography- tandem mass spectrometry method for plasma and saliva busulfan determination.
methodsAn online extraction cartridge with column-switching technique, analytical liquid chromatography over a Chromolith RP 18 e column, and tandem mass spectrometry were used to quantify busulfan concentrations in matched plasma and saliva samples. The study population consisted of ten patients, aged 1.3-19 years (median age 11.8 years, seven females, three males), undergoing haematopoietic stem cell transplantation. All patients received busulfan 0.8-1.3 mg/kg orally every 6 hours for a total of 16 doses, followed by two doses of cyclophosphamide (60 mg/kg/day).
resultsThe lowest limit of detection was 2 microg/L and the lower limit of quantification was 10 microg/L. Only 100 microL of plasma/saliva was needed. The mean recoveries (SD) of busulfan were 97.2% (2.7) in plasma and 100.4% (1.3) in saliva. Intra- and inter-assay imprecision was 2-3% and 2-4% for plasma, and 1-2% and 2-4% for saliva (concentration range 30-1,500 microg/L). The bias was <4% for both plasma and saliva. The correlation between the busulfan concentration in plasma and saliva was highly significant (r=0.958; p<0.0001; saliva/plasma ratio=1.09+/-0.04; n=69 sample pairs). The apparent plasma clearance was slightly higher than the apparent saliva clearance (202+/-31 mL/h/kg vs 189+/-28 mL/h/kg; p=0.001). The mean elimination half-life was found to be 2.31+/-0.46 hours for plasma and 2.30+/-0.36 hours for saliva; these were not significantly different (p=0.83).
conclusionThe present study demonstrated that busulfan analysis in saliva could be a valuable and reliable alternative to plasma analysis.
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