References
- 1. Nutescu E. Apixaban: a novel oral inhibitor of factor Xa. Am J Health Syst Pharm. 2012;69(13):1113-26. DOI: 10.2146/ajhp110418
- 2. Scaglione F. New oral anticoagulants: comparative pharmacology with vitamin K antagonists. Clin Pharmacokinet. 2013;52(2):69-82. DOI: 10.1007/s40262-012-0030-9
- 3. European Medicine Agency, Eliquis: Summary of Product Characteristics. Available at http://www.ema.\europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002148/WC500107728.pdf. Accessed October 23rd, 2014.
- 4. Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013 Aug 29;369(9):799-808. DOI: 10.1056/NEJMoa1302507
- 5. Cheng JW, Barillari G. Non-vitamin K antagonist oral anticoagulants in cardiovascular disease management: evidence and unanswered questions. J Clin Pharm Ther. 2014;39(2):118-35. DOI: 10.1111/jcpt.12122
- 6. Bruins Slot KM, Berge E. Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation. Cochrane Database Syst Rev. 2013 Aug 8;8:CD008980. DOI: 10.1002/14651858.CD008980.pub2
- 7. Bauer KA. Pros and cons of new oral anticoagulants. Management of Thromboembolic Disease. Hematology Am Soc Hematol Educ Program. 2013;2013:464-70. DOI: 10.1182/asheducation-2013.1.464
- 8. Levy JH, Faraoni D, Spring JL, Douketis JD, Samama CM. Managing New Oral Anticoagulants in the Perioperative and Intensive Care Unit Setting. Anesthesiology. 2013 Jun;118(6):1466-74. DOI: 10.1097/ ALN.0b013e318289bcba
- 9. Gogarten W, Vandermeulen E, Van Aken H, Kozek S, Llau JV, Samama CM. Regional anesthesia and antithrombotic agents: recommendations of the European society of Anaesthesiology. Eur J Anaesthesiol. 2010 Dec;27(12):999-1015. DOI: 10.1097/ EJA.0b013e32833f6f6f
- 10. Frost C, Wang J, Nepal S, Schuster A, Barrett YC, Mosqueda-Garcia R, et al. Apixaban, an oral, direct factor Xa inhibitor: single dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects. Br J Clin Pharmacol. 2013 Feb;75(2):476-87. DOI: 10.1111/j.1365-2125.2012.04369.x
- 11. Bauer KA. Pros and cons of new oral anticoagulants. Hematology Am Soc Hematol Educ Program. 2013;2013:464-70. DOI: 10.1182/asheducation-2013.1.464
- 12. Brieger D. Anticoagulation: a GP primer on the new oral anticoagulants. Aust Fam Physician. 2014;43(5):254-9.
- 13. Douxfils J, Chatelain C, Chatelain B, Dogné JM, Mullier F. Impact of apixaban on routine and specific coagulation assays: a practical laboratory guide. [Abstract] Thromb Haemost. 2013;110(2):283-94. DOI: 10.1160/ TH12-12-0898
- 14. Vílchez JA, Gallego P, Lip GYH. Safety of new oral anticoagulant drugs: a perspective. Ther Adv Drug Saf 2014;5(1):8-20. DOI: 10.1177/2042098613507945
- 15. Pernod G, Albaladejo P, Godier A, Samama CM, Susen S, Gruel Y, et al. Management of major bleeding complications and emergency surgery in patients on longterm treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors: proposals of the working group on perioperative haemostasis (GIHP) - March 2013. Arch Cardiovasc Dis. 2013;106(6-7):382-93. DOI: 10.1016/j.acvd.2013.04.009
- 16. Dincq AS, Lessire S, Douxfils J, Dogné JM, Gourdin M, Mullier F. Management of Non-Vitamin K Antagonist Oral Anticoagulants in the Perioperative Setting. Biomed Res Int. 2014;2014:385014. DOI: 10.1155/2014/385014
- 17. Eby C. Novel anticoagulants and laboratory testing. Int J Lab Hematol. 2013 Jun;35(3):262-8. DOI: 10.1111/ ijlh.12065
- 18. Gous T, Couchman L, Patel JP, Paradzai C, Arya R, Flanagan RJ. Measurement of the direct oral anticoagulants apixaban, dabigatran, edoxaban, and rivaroxaban in human plasma using turbulent flow liquid chromatography with high-resolution mass spectrometry. Ther Drug Monit. 2014 Oct;36(5):597-605. DOI: 10.1097/ FTD.0000000000000059
- 19. Korostelev M, Bihan K, Ferreol L, Tissot N, Hulot JS, Funck-Brentano C, et al. Simultaneous determination of rivaroxaban and dabigatran levels in human plasma by high-performance liquid chromatography-tandem mass spectrometry. J Pharm Biomed Anal. 2014 Nov;100:230-5. DOI: 10.1016/j.jpba.2014.08.011
- 20. Schmitz EM, Boonen K, van den Heuvel DJ, van Dongen JL, Schellings MW, Emmen JM, et al. Determination of dabigatran, rivaroxaban and apixaban by ultra- performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS) and coagulation assays for therapy monitoring of novel direct oral anticoagulants. J Thromb Haemost. 2014 Oct;12(10):1636-46. DOI: 10.1111/jth.12702
- 21. Raghavan N, Frost CE, Yu Z, He K, Zhang H, Humphreys WG, et al. Apixaban metabolism and pharmacokinetics after oral administration to humans. Drug Metab Dispos. 2009 Jan;37(1):74-81. DOI: 10.1124/ dmd.108.023143
- 22. Frost C, Nepal S, Wang J, Schuster A, Byon W, Boyd RA, et al. Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects. Br J Clin Pharmacol. 2013 Nov;76(5):776-86. DOI: 10.1111/bcp.12106
- 23. Cui Y, Song Y, Wang J, Yu Z, Schuster A, Barrett YC, et al. Single- and multiple-dose pharmacokinetics, pharmacodynamics, and safety of apixaban in healthy Chinese subjects. Clin Pharmacol. 2013 Dec 6;5:177-84. DOI: 10.2147/CPAA.S51981
- 24. Delavenne X, Mismetti P, Basset T. Rapid determination of apixaban concentration in human plasma by liquid chromatography/tandem mass spectrometry: application to pharmacokinetic study. J Pharm Biomed Anal. 2013 May 5;78-79:150-3. DOI: 10.1016/j. jpba.2013.02.007
- 25. Upreti VV, Wang J, Barrett YC, Byon W, Boyd RA, Pursley J, et al. Effect of extremes of body weight on the pharmacokinetics, pharmacodynamics, safety and tolerability of apixaban in healthy subjects. Br J Clin Pharmacol. 2013 Dec;76(6):908-16. DOI: 10.1111/ bcp.12114
- 26. Wang X, Mondal S, Wang J, Tirucherai G, Zhang D, Boyd RA, et al. Effect of activated charcoal on apixaban pharmacokinetics in healthy subjects. Am J Cardiovasc Drugs. 2014 Apr;14(2):147-54. DOI: 10.1007/ s40256-013-0055-y
- 27. Gouin-Thibault I, Flaujac C, Delavenne X, Quenet S, Horellou MH, Laporte S, et al. Assessment of apixaban plasma levels by laboratory tests: suitability of three anti-Xa assays. A multicentre French GEHT study. Thromb Haemost. 2014 Feb;111(2):240-8. DOI: 10.1160/TH13-06-0470
- 28. Guidance for Industry, Bioanalytical Method Validation. U.S. Department of Health and Human Services, Food and Drug Administration. Federal Register. 2001;66.
- 29. Guidance on the Investigation of Bioavailability and Bioequivalence. The European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products. 2001; CPMP/EWP/QWP/1401/98.
- 30. Imre S, Vlase L, Muntean DL. Bioanalytical method validation. Rev Romana Med Lab. 2008;10(1):13-21.
- 31. Guideline on bioanalytical method validation. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). 275542 / 2014. http:// www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf
- 32. 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). September 2013 http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368107.pdf