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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