Juvenile rat and pediatric trazodone studies: how to gain extra sensitivity to overcome bioanalytical challenges.
BIOANALYSIS(2019)
Abstract
Aim: Trazodone (TZD)is used for the treatment of depression in adults and, off-label, as a sleep medication in adult and pediatric populations. The off-label use is well documented, however further clinical studies are needed to confirm its efficacy and safety for the treatment of sleep disorders. In this scenario, we developed a bioanalytical method to quantify low TZD concentrations in samples collected by capillary microsampling (CMS) to support dose finding, Good Laboratory Practice juvenile rat toxicokinetic and upcoming pediatric studies. Methodology: A method using only 8l of plasma was developed and successfully used for analyzing CMS samples from juvenile rats throughout toxicokinetic study. Conclusion: By harmoniously maximizing each analytical step, we achieved a sensitive method to quantify TZD in CMS samples.
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Key words
capillary microsampling,CMS,juvenile rats,LC-MS,MS,toxicokinetic study,trazodone
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