Applying dried blood spot sampling with LCMS quantification in the clinical development phase of tasquinimod-Reference-Cited by-同舟云学术

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

Published:2015-01 Issue:2 Volume:7 Page:179-191
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Svensson Leif D¹,Sennbro Carl-Johan²,Svanström Camilla³,Hansson Gunnar P⁴

Affiliation:

1. Active Biotech AB, Lund, Sweden

2. Formerly Active Biotech AB but now LEO Pharma, Ballerup, Denmark

3. Formerly Active BiotechAB but now Repligen AB, Lund, Sweden

4. Formerly Active Biotech AB but now IFKAN AB, Hässleholm, Sweden

Abstract

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.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio.14.259

Reference23 articles.

1. Long-term Survival and Biomarker Correlates of Tasquinimod Efficacy in a Multicenter Randomized Study of Men with Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer

2. Bioanalysis in clinical development of tasquinimod using liquid chromatography/tandem mass spectrometry

3. Quantitative determination of the anti-tumor agent tasquinimod in human urine by liquid chromatography–tandem mass spectrometry

4. Dried Blood Spots as a Sample Collection Technique for the Determination of Pharmacokinetics in Clinical Studies: Considerations for the Validation of a Quantitative Bioanalytical Method

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