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

被引：18

作者：

Verheijen, Remy B. ^{[1
]}

Bins, Sander ^{[2
]}

Thijssen, Bas ^{[1
]}

Rosing, Hilde ^{[1
]}

Nan, Lianda ^{[1
]}

Schellens, Jan H. M. ^{[3
,4
]}

Mathijssen, Ron H. J. ^{[2
]}

Lolkema, Martijn P. ^{[2
,5
]}

Beijnen, Jos H. ^{[1
,4
]}

Steeghs, Neeltje ^{[3
,5
]}

Huitema, Alwin D. R. ^{[1
]}

机构：

[1] Netherlands Canc Inst Antoni van Leeuwenhoek, Dept Pharm & Pharmacol, NL-1066 CX Amsterdam, Netherlands

[2] Erasmus MC Canc Inst, Dept Med Oncol, NL-3015 CE Rotterdam, Netherlands

[3] Netherlands Canc Inst Antoni van Leeuwenhoek, Dept Med Oncol & Clin Pharmacol, NL-1066 CX Amsterdam, Netherlands

[4] Univ Utrecht, Dept Pharmaceut Sci, NL-3584 CG Utrecht, Netherlands

[5] Univ Med Ctr Utrecht, Dept Med Oncol, NL-3584 CX Utrecht, Netherlands

来源：

BIOANALYSIS | 2016年 / 8卷 / 02期

关键词：

clinical validation; DBS; pazopanib; PK; therapeutic drug monitoring; DRIED BLOOD SPOTS; TANDEM MASS-SPECTROMETRY; RENAL-CELL CARCINOMA; MICROSAMPLING CONSORTIUM; ADVANCED CANCER; HUMAN SERUM; INHIBITOR; TAMOXIFEN; PLASMA; TRIAL;

D O I：

10.4155/bio.15.235

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

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 g/ml compared with patients with lower concentrations. 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). Conclusion: The method was successfully validated, applied to paired clinical samples and is suitable for application to therapeutic drug monitoring of pazopanib.

引用

页码：123 / 134

页数：12

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