Dried Blood Spot Methodology in Combination with Liquid Chromatography/Tandem Mass Spectrometry Facilitates the Monitoring of Teriflunomide

Therapeutic Drug Monitoring

Volumn 38, Issue 4, 2016, Pages 471-482

  Filali Ansary, Aziz ^a   Lunven, Catherine ^a   Turpault, Sandrine ^a   Beyer, Yann Joel ^a   O'Brien, Amy ^a   Delfolie, Astrid ^a   Boyanova, Neli ^b   Sanderink, Ger Jan ^a   Baldinetti, Francesca ^b  

^a SANOFI   (France)

^b GENZYME CORPORATION   (United States)

Author keywords

dried blood spot; LC MS MS; teriflunomide

Indexed keywords

TERIFLUNOMIDE; CROTONIC ACID DERIVATIVE; TOLUIDINE DERIVATIVE;

ADULT; ARTICLE; BLOOD; BLOOD SAMPLING; BLOOD-TO-PLASMA RATIO; CONTROLLED STUDY; DRIED BLOOD SPOT TESTING; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG MONITORING; DRUG SCREENING; DRUG STABILITY; FEMALE; HEMATOCRIT; HUMAN; HUMAN EXPERIMENT; HUMIDITY; IN VIVO STUDY; LIQUID CHROMATOGRAPHY; MALE; MEASUREMENT ACCURACY; NORMAL HUMAN; PRIORITY JOURNAL; ROOM TEMPERATURE; STORAGE TEMPERATURE; TANDEM MASS SPECTROMETRY; TIME; CHEMISTRY; PLASMA; PROCEDURES; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY;

BLOOD SPECIMEN COLLECTION; CHROMATOGRAPHY, LIQUID; CROTONATES; DRIED BLOOD SPOT TESTING; DRUG STABILITY; HEMATOCRIT; HUMANS; PLASMA; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; TANDEM MASS SPECTROMETRY; TOLUIDINES;

EID: 84961616007     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0000000000000302     Document Type: Article

References (43)

1. Aubagio [teriflunomide film-coated tablets]. EU Summary of Product Characteristics. Sanofi-Aventis; 2015. Available at: http://www.ema. europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/002514/WC500148682.pdf. Accessed August 21, 2015
2. Guthrie R, Susi A. A simple phenylalanine method for detecting phenylketonuria in large populations of new born infants. Pediatrics. 1963;32: 338-343
3. Lakshmy R. Analysis of the use of dried blood spot measurements in disease screening. J Diabetes Sci Technol. 2008;2:242-243
4. Parker SP, Cubitt WD. The use of the dried blood spot sample in epidemiological studies. J Clin Pathol. 1999;52:633-639
5. Sharma A, Jaiswal S, Shukla M, et al. Dried blood spots: concepts, present status, and future perspectives in bioanalysis. Drug Test Anal. 2014;6:399-414
6. Edelbroek PM, van der Heijden J, Stolk LM. Dried blood spot methods in therapeutic drug monitoring: methods, assays, and pitfalls. Ther Drug Monit. 2009;31:327-336
7. Linder C, Andersson M, Wide K, et al. A LC-MS/MS method for therapeutic drug monitoring of carbamazepine, lamotrigine and valproic acid in DBS. Bioanalysis. 2015;7:2031-2039
8. van der Elst KC, Span LF, van Hateren K, et al. Dried blood spot analysis suitable for therapeutic drug monitoring of voriconazole, fluconazole, and posaconazole. Antimicrob Agents Chemother. 2013;57: 4999-5004
9. Verweij-van CP, Graaff-Teulen MJ, Kanter CT, et al. Determination of the HCV protease inhibitor telaprevir in plasma and dried blood spot by liquid chromatography-tandem mass spectrometry. Ther Drug Monit. 2015;37:626-633
10. Lakshmy R, Mathur P, Gupta R, et al. Measurement of cholesterol and triglycerides from a dried blood spot in an Indian Council of Medical Research-World Health Organization multicentric survey on risk factors for noncommunicable diseases in India. J Clin Lipidol. 2012;6:33-41
11. Heath AK, Williamson EJ, Ebeling PR, et al. Measurements of 25-hydroxyvitamin D concentrations in archived dried blood spots are reliable and accurately reflect those in plasma. J Clin Endocrinol Metab. 2014; 99:3319-3324
12. Giordano G, Di Gangi IM, Gucciardi A, et al. Quantification of underivatised amino acids on dry blood spot, plasma, and urine by HPLC-ESIMS/ MS. Methods Mol Biol. 2012;828:219-242
13. McDade TW, Williams S, Snodgrass JJ. What a drop can do: dried blood spots as a minimally invasive method for integrating biomarkers into population-based research. Demography. 2007;44:899-925
14. Li W, Tse FL. Dried blood spot sampling in combination with LC-MS/ MS for quantitative analysis of small molecules. Biomed Chromatogr. 2010;24:49-65
15. Organisation for Economic Cooperation and Development. Principles on Good Laboratory Practice (As Revised in 1997), Series on Principles of Good Laboratory Practice and Compliance Monitoring, No 1, OECD, ENV/MC/CHEM/(98). Paris, France: OECD; 1998
16. Food and Drug Administration. Guidance for Industry: Bioanalytical Method Validation Center for Drug Evaluation and Research. Silver Springs, MD: FDA; 2001
17. European Medicines Agency. Guideline on Bioanalytical Method Validation. EMEA/CHMP/EWP/192217/2009. London, UK: EMA; 2011
18. Vessman J. Selectivity or specificity? validation of analytical methods from the perspective of an analytical chemist in the pharmaceutical industry. J Pharm Biomed Anal. 1996;14:867-869
19. Matuszewski BK, Constanzer ML, Chavez-Eng CM. Matrix effect in quantitative LC/MS/MS analyses of biological fluids: a method for determination of finasteride in human plasma at picogram per milliliter concentrations. Anal Chem. 1998;70:882-889
20. Benijts T, Dams R, Lambert W, et al. Countering matrix effects in environmental liquid chromatography-electrospray ionization tandem mass spectrometry water analysis for endocrine disrupting chemicals. J Chromatogr A. 2004;1029:153-159
21. Chambers E, Wagrowski-Diehl DM, Lu Z, et al. Systematic and comprehensive strategy for reducing matrix effects in LC/MS/MS analyses. J Chromatogr B Analyt Technol Biomed Life Sci. 2007;852:22-34
22. Trufelli H, Palma P, Famiglini G, et al. An overview of matrix effects in liquid chromatography-mass spectrometry. Mass Spectrom Rev. 2011;30: 491-509
23. SAS Institute Inc. SAS/STAT User's Guide, Version 8. Cary, NC: SAS Institute Inc; 1999
24. Denniff P, Woodford L, Spooner N. Effect of ambient humidity on the rate at which blood spots dry and the size of the spot produced. Bioanalysis. 2013;5:1863-1871
25. Holub M, Tuschl K, Ratschmann R, et al. Influence of hematocrit and localisation of punch in dried blood spots on levels of amino acids and acylcarnitines measured by tandem mass spectrometry. Clin Chim Acta. 2006;373:27-31
26. Adam BW, Alexander JR, Smith SJ, et al. Recoveries of phenylalanine from two sets of dried-blood-spot reference materials: prediction from hematocrit, spot volume, and paper matrix. Clin Chem. 2000;46: 126-128
27. Denniff P, Spooner N. The effect of hematocrit on assay bias when using DBS samples for the quantitative bioanalysis of drugs. Bioanalysis. 2010;2:1385-1395
28. Evans CA, Bowen CL, Filali-Ansari A. Dried blood spots: challenges. In: Zane P, Emmons GT, eds. Microsampling in Pharmaceutical Bioanalysis. London, United Kingdom: Future Science Ltd; 2013: 30-46
29. Berm EJ, Brummel-Mulder E, Paardekooper J, et al. Determination of venlafaxine and O-desmethylvenlafaxine in dried blood spots for TDM purposes, using LC-MS/MS. Anal Bioanal Chem. 2014;406: 2349-2353
30. Liu G, Snapp HM, Ji QC. Internal standard tracked dilution to overcome challenges in dried blood spots and robotic sample preparation for liquid chromatography/tandem mass spectrometry assays. Rapid Commun Mass Spectrom. 2011;25:1250-1256
31. Mitchell C, Kraft K, Peterson D, et al. Cross-contamination during processing of dried blood spots used for rapid diagnosis of HIV-1 infection of infants is rare and avoidable. J Virol Methods. 2010;163: 489-491
32. Bull BS, Koepke JA, Simson E, et al. Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard. NCCLS Document H7-A3. 2000;20(18)
33. Webb NJ, Roberts D, Preziosi R, et al. Fingerprick blood samples can be used to accurately measure tacrolimus levels by tandem mass spectrometry. Pediatr Transplant. 2005;9:729-733
34. Lelong C, Wickremsinhe E, Filali-Ansary A, et al. Training and microsample collection. In: Zane P, Emmons GT, eds. Microsampling in Pharmaceutical Bioanalysis. London, United Kingdom: Future Science Ltd; 2013: 14-28
35. Ostler MW, Porter JH, Buxton OM. Dried blood spot collection of health biomarkers to maximize participation in population studies. J Vis Exp. 2014;Jan 28 (83):e50973
36. Fast DM, Kelley M, Viswanathan CT, et al. Workshop report and follow-up-AAPS workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples-implications of crystal city recommendations. AAPS J. 2009;11:238-241
37. Timmerman P, Luedtke S, van Amsterdam P, et al. Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum. Bioanalysis. 2009;1:1049-1056
38. Passing H, Bablok L. A new biometrical procedure for testing the equality of measurements from two different analytical methods. application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem. 1983;21:709-720
39. Hawkins DM. Diagnostics for conformity of paired quantitative measurements. Stat Med. 2002;21:1913-1935
40. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;1:307-310
41. Liang X, Li Y, Barfield M, et al. Study of dried blood spots technique for the determination of dextromethorphan and its metabolite dextrorphan in human whole blood by LC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2009;877:799-806
42. Wood S, Neudert L, Meunier L, et al. Assessment of factors influencing method precision in a human dried blood spot assay for the determination of a novel analyte. Dried Blood Spot Sampling in the Pharmaceutical Industry (Meeting); Philadelphia, USA; May 3-4, 2011
43. Hon GM, Hassan MS, van Rensburg SJ, et al. The Haematological profile of patients with multiple sclerosis. Open J Mod Neurosurg. 2012;2:36-44