1. Juvenile rat and pediatric trazodone studies: how to gain extra sensitivity to overcome bioanalytical challenges.
- Author
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Olivieri S, Bovi G, Petrucci V, Alfieri A, Oggianu L, Picollo R, Devastato C, Dragone P, Garofolo F, and Tongiani S
- Subjects
- Animals, Anti-Anxiety Agents administration & dosage, Blood Specimen Collection instrumentation, Calibration, Capillaries, Chromatography, Liquid, Dose-Response Relationship, Drug, Female, Male, Rats, Reference Standards, Reproducibility of Results, Sensitivity and Specificity, Tandem Mass Spectrometry, Toxicokinetics, Trazodone administration & dosage, Anti-Anxiety Agents blood, Blood Specimen Collection methods, Trazodone blood
- 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 8 μl 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.
- Published
- 2019
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