Dried Blood Spot Technique for the Monitoring of Ambrisentan, Bosentan, Sildenafil, and Tadalafil in Patients with Pulmonary Arterial Hypertension

Analytical Chemistry

Volumn 87, Issue 24, 2015, Pages 12112-12120

  Enderle, Yeliz ^a   Meid, Andreas D ^a   Friedrich, Jörg ^a   Grünig, Ekkehard ^b   Wilkens, Heinrike ^c   Haefeli, Walter E ^a   Burhenne, Jürgen ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b UNIVERSITY OF HEIDELBERG   (Germany)

^c SAARLAND UNIVERSITY   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ASSAYS; ENZYME INHIBITION; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY;

DRIED BLOOD SPOT (DBS); LIQUID CHROMATOGRAPHY/TANDEM MASS SPECTROMETRY; LIQUID/LIQUID EXTRACTION; LOWER LIMIT OF QUANTIFICATIONS; PHOSPHODIESTERASE 5 INHIBITORS; PULMONARY ARTERIAL HYPERTENSION; PULMONARY ARTERIAL HYPERTENSION (PAH); QUANTIFICATION METHODS;

BLOOD;

AMBRISENTAN; BOSENTAN; PHENYLPROPIONIC ACID DERIVATIVE; PYRIDAZINE DERIVATIVE; SILDENAFIL; SULFONAMIDE; TADALAFIL;

BLOOD; DRIED BLOOD SPOT TESTING; HUMAN; LIMIT OF DETECTION; LIQUID CHROMATOGRAPHY; PROCEDURES; PULMONARY HYPERTENSION; REPRODUCIBILITY; TANDEM MASS SPECTROMETRY;

CHROMATOGRAPHY, LIQUID; DRIED BLOOD SPOT TESTING; HUMANS; HYPERTENSION, PULMONARY; LIMIT OF DETECTION; PHENYLPROPIONATES; PYRIDAZINES; REPRODUCIBILITY OF RESULTS; SILDENAFIL CITRATE; SULFONAMIDES; TADALAFIL; TANDEM MASS SPECTROMETRY;

EID: 84950114746     PISSN: 00032700     EISSN: 15206882     Source Type: Journal    
DOI: 10.1021/acs.analchem.5b03077     Document Type: Article

References (45)

1. OCallaghan, D. S.; Humbert, M. Eur. Respir. Rev. 2012, 21, 218-222 10.1183/09059180.00003512
2. Galiè, N.; Brundage, B. H.; Ghofrani, H. A.; Oudiz, R. J.; Simonneau, G.; Safdar, Z.; Shapiro, S.; White, R. J.; Chan, M.; Beardsworth, A.; Frumkin, L.; Barst, R. J. Circulation 2009, 119, 2894-2903 10.1161/CIRCULATIONAHA.108.839274
3. Galiè, N.; Ghofrani, H. A.; Torbicki, A.; Barst, R. J.; Rubin, L. J.; Badesch, D.; Fleming, T.; Parpia, T.; Burgess, G.; Branzi, A.; Grimminger, F.; Kurzyna, M.; Simonneau, G. N. N. Engl. J. Med. 2005, 353, 2148-2157 10.1056/NEJMoa050010
4. Rubin, L. J.; Badesch, D. B.; Barst, R. J.; Galie, N.; Black, C. M.; Keogh, A.; Pulido, T.; Frost, A.; Roux, S.; Leconte, I.; Landzberg, M.; Simonneau, G. N. N. Engl. J. Med. 2002, 346, 896-903 10.1056/NEJMoa012212
5. Pulido, T.; Adzerikho, I.; Channick, R. N.; Delcroix, M.; Galiè, N.; Ghofrani, H. A.; Jansa, P.; Jing, Z. C.; Le Brun, F. O.; Mehta, S.; Mittelholzer, C. M.; Perchenet, L.; Sastry, B. K.; Sitbon, O.; Souza, R.; Torbicki, A.; Zeng, X.; Rubin, L. J.; Simonneau, G. N. N. Engl. J. Med. 2013, 369, 809-818 10.1056/NEJMoa1213917
6. Oudiz, R. J.; Galiè, N.; Olschewski, H.; Torres, F.; Frost, A.; Ghofrani, H. A.; Badesch, D. B.; McGoon, M. D.; McLaughlin, V. V.; Roecker, E. B.; Harrison, B. C.; Despain, D.; Dufton, C.; Rubin, L. J. J. Am. Coll. Cardiol. 2009, 54, 1971-1981 10.1016/j.jacc.2009.07.033
7. Fernandes, C. J.; Martins, B. C.; Jardim, C. V.; Ciconelli, R. M.; Morinaga, L. K.; Breda, A. P.; Hoette, S.; Souza, R. Health. Qual. Life Outcomes 2014, 12 130 10.1186/s12955-014-0130-3
8. Galiè, N.; Manes, A.; Negro, L.; Palazzini, M.; Bacchi-Reggiani, M. L.; Branzi, A. Eur. Heart J. 2009, 30, 394-403 10.1093/eurheartj/ehp022
9. Markert, C.; Burhenne, J.; Weiss, J.; Mikus, G.; Haefeli, W. E. Clin. Pharmacol. Ther. 2014, 95, 250-251 10.1038/clpt.2013.188
10. Venitz, J.; Zack, J.; Gillies, H.; Allard, M.; Regnault, J.; Dufton, C. J. Clin. Pharmacol. 2012, 52, 1784-1805 10.1177/0091270011423662
11. Waxman, A.; Chen, S. Y.; Boulanger, L.; Watson, J. A.; Golden, G. J. Med. Econ. 2013, 16, 298-306 10.3111/13696998.2012.756399
12. Spangler, M. L.; Saxena, S. Clin. Ther. 2010, 32, 53-56 10.1016/j.clinthera.2010.01.004
13. Oudiz, R. J.; Brundage, B. H.; Galiè, N.; Ghofrani, H. A.; Simonneau, G.; Botros, F. T.; Chan, M.; Beardsworth, A.; Barst, R. J. J. Am. Coll. Cardiol. 2012, 60, 768-774 10.1016/j.jacc.2012.05.004
14. Hesse, C.; Siedler, H.; Burhenne, J.; Riedel, K. D.; Haefeli, W. E. J. Clin. Psychopharmacol. 2005, 25, 589-592 10.1097/01.jcp.0000186866.82665.29
15. Sidharta, P. N.; Treiber, A.; Dingemanse, J. Clin. Pharmacokinet. 2015, 54, 457-471 10.1007/s40262-015-0255-5
16. Contreras Zavala, L.; Rivera Espinosa, L.; ángeles Moreno, A. P.; Ramírez San-Juan, E.; Zamudio Hernández, S.; García González, A.; Marcelín Jiménez, G. Bioanalysis 2014, 6, 2815-2824 10.4155/bio.14.126
17. Pandya, H. C.; Spooner, N.; Mulla, H. Bioanalysis 2011, 3, 779-86 10.4155/bio.11.19
18. Koster, R.; Touw, D.; Alffenaar, J. J. Appl. Bioanalysis 2015, 1, 38-41 10.17145/jab.15.007
19. Timmerman, P.; White, S.; Globig, S.; Lüdtke, S.; Brunet, L.; Smeraglia, J. Bioanalysis 2011, 3, 1567-1575 10.4155/bio.11.132
20. Guidance for Industry: Bioanalytical Method Validation. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), May 2001; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070107.pdf (accessed July 28, 2015).
21. Guideline on bioanalytical method validation. European Medicines Agency, 21 July 2011; http://www.ema.europa.eu/docs/en
22. Markert, C.; Hellwig, R.; Burhenne, J.; Hoffmann, M. M.; Weiss, J.; Mikus, G.; Haefeli, W. E. Eur. J. Clin. Pharmacol. 2013, 69, 1785-1793 10.1007/s00228-013-1529-1
23. Markert, C.; Schweizer, Y.; Hellwig, R.; Wirsching, T.; Riedel, K. D.; Burhenne, J.; Weiss, J.; Mikus, G.; Haefeli, W. E. Br. J. Clin. Pharmacol. 2014, 77, 141-148 10.1111/bcp.12177
24. Weiss, J.; Theile, D.; Spalwisz, A.; Burhenne, J.; Riedel, K. D.; Haefeli, W. E. Biochem. Pharmacol. 2013, 85, 265-273 10.1016/j.bcp.2012.11.020
25. Carls, A.; Winter, J.; Enderle, Y.; Burhenne, J.; Gorenflo, M.; Haefeli, W. E. J. Med. Case Rep. 2014, 8 171 10.1186/1752-1947-8-171
26. Bowen, C. L.; Dopson, W.; Kemp, D. C.; Lewis, M.; Lad, R.; Overvold, C. Bioanalysis 2011, 3, 1625-1633 10.4155/bio.11.128
27. Wilhelm, A. J.; den Burger, J. C.; Swart, E. L. Clin. Pharmacokinet. 2014, 53, 961-973 10.1007/s40262-014-0177-7
28. Oliveira, R. V.; Henion, J.; Wickremsinhe, E. Anal. Chem. 2014, 86, 1246-1253 10.1021/ac403672u
29. Shah, N. M.; Hawwa, A. F.; Millership, J. S.; Collier, P. S.; McElnay, J. C. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2013, 923-924, 65-73 10.1016/j.jchromb.2013.02.005
30. Ganz, N.; Singrasa, M.; Nicolas, L.; Gutierrez, M.; Dingemanse, J.; Döbelin, W.; Glinski, M. J. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2012, 885-886, 50-60 10.1016/j.jchromb.2011.12.012
31. Cornbleet, P. J.; Gochman, N. Clin. Chem. 1979, 25, 432-438
32. Linnet, K. Clin. Chem. 1993, 39, 424-432
33. Carstensen, B.; Gurrin, L.; Ekstrom, C.; Figurski, M. MethComp: Functions for Analysis of Agreement in Method Comparison Studies, 2015; http://cran.r-project.org/web/packages/MethComp/index.html (accessed July 28, 2015).
34. Development Core Team. R, a language and environment for statistical computing, version 3.1.0. R Foundation for Statistical Computing, Vienna, Austria, 2014.
35. Burhenne, J.; Halama, B.; Maurer, M.; Riedel, K. D.; Hohmann, N.; Mikus, G.; Haefeli, W. E. Anal. Bioanal. Chem. 2012, 402, 2439-2450 10.1007/s00216-011-5675-y
36. Koster, R. A.; Alffenaar, J. W.; Botma, R.; Greijdanus, B.; Touw, D. J.; Uges, D. R.; Kosterink, J. G. Bioanalysis 2015, 7, 345-351 10.4155/bio.14.298
37. De Kesel, P. M.; Sadones, N.; Capiau, S.; Lambert, W. E.; Stove, C. P. Bioanalysis 2013, 5, 2023-2041 10.4155/bio.13.156
38. Wilhelm, A. J.; Klijn, A.; den Burger, J. C. G.; Visser, O. J.; Veldkamp, A. I.; Janssen, J. J. W.; Swart, E. L. Ther. Drug Monit. 2013, 35, 92-95 10.1097/FTD.0b013e31827d76ce
39. Vu, D. H.; Koster, R. A.; Alffenaar, J. W. C.; Brouwers, J. R. B. J.; Uges, D. R. A. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2011, 879, 1063-1070 10.1016/j.jchromb.2011.03.017
40. Muirhead, G. J.; Rance, D. J.; Walker, D. K.; Wastall, P. Br. J. Clin. Pharmacol. 2002, 53, 13S-20S 10.1046/j.06-5251.2001.00028.x
41. Volibris (Ambrisentan), Annexes I-III. European Medicines Agency; http://www.ema.europa.eu/docs/en GB/document library/EPAR Product Information/human/000839/WC500053065.pdf (accessed July 28, 2015).
42. Meyer, J. F. Hoffmann-La Roche Ltd Research Report B-158760, 1996.
43. Tracleer (Bosentan), Annexes I-IV. European Medicines Agency; http://www.ema.europa.eu/docs/en GB/document library/EPAR Product Information/human/000401/WC500041597.pdf (accessed July 28, 2015).
44. Emmons, G.; Rowland, M. Bioanalysis 2010, 2, 1791-1796 10.4155/bio.10.159
45. Wickremsinhe, E. R.; Huang, N. H.; Abdul, B. G.; Knotts, K.; Ruterbories, K. J.; Manro, J. R. Bioanalysis 2013, 5, 159-170 10.4155/bio.12.309