Development and clinical validation of an LC-MS/MS method for the quantification of pazopanib in DBS.

Abstract

CONCLUSION

The method was successfully validated, applied to paired clinical samples and is suitable for application to therapeutic drug monitoring of pazopanib.

METHODS & RESULTS

We developed a DBS assay as a patient friendly approach to guide treatment. The method was validated according to US FDA and EMA guidelines and European Bioanalysis Forum recommendations. Influence of spot homogeneity, spot volume and hematocrit were shown to be within acceptable limits. Analysis of paired clinical samples showed a good correlation between the measured plasma and DBS concentrations (R(2) of 0.872).

BACKGROUND

Pazopanib is approved for the treatment of renal cell carcinoma and soft tissue sarcoma. Analyses show increased benefit in patients with plasma trough concentrations ≥20.5 μg/ml compared with patients with lower concentrations.

More about this publication

Bioanalysis
  • Volume 8
  • Issue nr. 2
  • Pages 123-34
  • Publication date 15-12-2015

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