Applying dried blood spot sampling with LCMS quantification in the clinical development phase of tasquinimod

被引：4

作者：

Svensson, Leif D. ^{[1
]}

Sennbro, Carl-Johan ^{[2
]}

Svanstrom, Camilla ^{[3
]}

Hansson, Gunnar P. ^{[4
]}

机构：

[1] Act Biotech AB, Lund, Sweden

[2] LEO Pharma, Ballerup, Denmark

[3] Repligen AB, Lund, Sweden

[4] IFKAN AB, Hassleholm, Sweden

来源：

BIOANALYSIS | 2015年 / 7卷 / 02期

关键词：

BIOANALYSIS; DBS; HEMATOCRIT;

D O I：

10.4155/bio.14.259

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Background: Tasquinimod is an orally active anticancer drug in late clinical development. Here we describe the development and validation of a bioanalytical method based upon dried blood spot analysis in combination with LCMS/MS and stable isotope dilution. Results & discussion: The present method was validated for accuracy, precision, linearity, selectivity, carry-over and ruggedness. Data elucidating stability of tasquinimod in dried blood spots and in blood at ambient temperature was investigated and found adequate. Furthermore, in a clinical study, incurred samples reanalysis was performed, and the correlation of blood concentration versus plasma concentrations of tasquinimod was investigated. Conclusion: The method described here is suitable for bioanalysis of tasquinimod in whole blood from humans in clinical studies.

引用

收藏

页码：179 / 191

页数：13

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