{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T19:09:11Z","timestamp":1793387351258,"version":"4.5.0"},"reference-count":44,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T00:00:00Z","timestamp":1709251200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T00:00:00Z","timestamp":1709251200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2024,1,24]],"date-time":"2024-01-24T00:00:00Z","timestamp":1706054400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100015774","name":"University of Malta","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100015774","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","thrombosisresearch.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Thrombosis Research"],"published-print":{"date-parts":[[2024,3]]},"DOI":"10.1016\/j.thromres.2024.01.017","type":"journal-article","created":{"date-parts":[[2024,1,23]],"date-time":"2024-01-23T21:40:10Z","timestamp":1706046010000},"page":"41-51","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":7,"special_numbering":"C","title":["A comparative in vitro study of the anticoagulant effect of branded versus generic rivaroxaban"],"prefix":"10.1016","volume":"235","author":[{"given":"Karl","family":"Mangion","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Vella","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Gatt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy Marie","family":"Vella","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marica","family":"Borg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denise","family":"Borg-Aquilina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Douxfils","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liberato","family":"Camilleri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicoletta","family":"Riva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"2","key":"10.1016\/j.thromres.2024.01.017_bb0005","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1111\/jth.13912","article-title":"Laboratory testing in patients treated with direct oral anticoagulants: a practical guide for clinicians","volume":"16","author":"Douxfils","year":"2018","journal-title":"J. Thromb. Haemost."},{"issue":"1","key":"10.1016\/j.thromres.2024.01.017_bb0010","doi-asserted-by":"crossref","first-page":"206","DOI":"10.1007\/s11239-015-1310-7","article-title":"Guidance for the practical management of the direct oral anticoagulants (DOACs) in VTE treatment","volume":"41","author":"Burnett","year":"2016","journal-title":"J. Thromb. Thrombolysis"},{"issue":"6","key":"10.1016\/j.thromres.2024.01.017_bb0015","doi-asserted-by":"crossref","first-page":"497","DOI":"10.1016\/j.thromres.2010.09.008","article-title":"The mechanism of action of rivaroxaban - an oral, direct factor Xa inhibitor - compared with other anticoagulants","volume":"127","author":"Samama","year":"2011","journal-title":"Thromb. Res."},{"issue":"3","key":"10.1016\/j.thromres.2024.01.017_bb0020","doi-asserted-by":"crossref","first-page":"376","DOI":"10.1161\/ATVBAHA.110.202978","article-title":"Rivaroxaban: a new oral factor Xa inhibitor","volume":"30","author":"Perzborn","year":"2010","journal-title":"Arterioscler. Thromb. Vasc. Biol."},{"issue":"10264","key":"10.1016\/j.thromres.2024.01.017_bb0025","doi-asserted-by":"crossref","first-page":"1767","DOI":"10.1016\/S0140-6736(20)32439-9","article-title":"Direct oral anticoagulants: evidence and unresolved issues","volume":"396","author":"Chan","year":"2020","journal-title":"Lancet"},{"issue":"2","key":"10.1016\/j.thromres.2024.01.017_bb0030","doi-asserted-by":"crossref","first-page":"352","DOI":"10.1111\/cts.12719","article-title":"Predicting cost-effectiveness of generic vs. brand dabigatran using pharmacometric estimates among patients with atrial fibrillation in the United States","volume":"13","author":"Wang","year":"2020","journal-title":"Clin. Transl. Sci."},{"issue":"6","key":"10.1016\/j.thromres.2024.01.017_bb0035","doi-asserted-by":"crossref","first-page":"e742","DOI":"10.4088\/JCP.15f10094","article-title":"Bioequivalence of generic drugs: a simple explanation for a US Food and Drug Administration requirement","volume":"76","author":"Andrade","year":"2015","journal-title":"J. Clin. Psychiatry"},{"key":"10.1016\/j.thromres.2024.01.017_bb0040","unstructured":"European Medicines Agency. Guideline for the investigation of bioequivalence. 2010 (Doc. Ref.: CPMP\/EWP\/QWP\/1401\/98 Rev.1\/ Corr) (Accessed 8 March 2023). Available from: https:\/\/www.ema.europa.eu\/en\/investigation-bioequivalence-scientific-guideline."},{"key":"10.1016\/j.thromres.2024.01.017_bb0045","unstructured":"European Medicines Agency. Rivaroxaban film-coated tablets 2.5, 10, 15 and 20mg product-specific bioequivalence guidance. 2016 (EMA\/CHMP\/160650\/2016) (Accessed 8 March 2023). Available from: https:\/\/www.ema.europa.eu\/en\/rivaroxaban-product-specific-bioequivalence-guidance."},{"issue":"1","key":"10.1016\/j.thromres.2024.01.017_bb0050","doi-asserted-by":"crossref","first-page":"133","DOI":"10.1111\/j.1538-7836.2010.04098.x","article-title":"Effects of the oral, direct factor Xa inhibitor rivaroxaban on commonly used coagulation assays","volume":"9","author":"Hillarp","year":"2011","journal-title":"J. Thromb. Haemost."},{"issue":"11","key":"10.1016\/j.thromres.2024.01.017_bb0055","doi-asserted-by":"crossref","first-page":"1810","DOI":"10.1111\/jth.12720","article-title":"Comparison of the effects of apixaban and rivaroxaban on prothrombin and activated partial thromboplastin times using various reagents","volume":"12","author":"Dale","year":"2014","journal-title":"J. Thromb. Haemost."},{"issue":"8","key":"10.1016\/j.thromres.2024.01.017_bb0060","doi-asserted-by":"crossref","first-page":"1008","DOI":"10.1055\/a-1450-8178","article-title":"2021 update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants","volume":"121","author":"Douxfils","year":"2021","journal-title":"Thromb. Haemost."},{"key":"10.1016\/j.thromres.2024.01.017_bb0065","doi-asserted-by":"crossref","first-page":"171","DOI":"10.1016\/j.thromres.2020.07.031","article-title":"Diagnostic performance of coagulation indices for direct oral anticoagulant concentration","volume":"195","author":"Zhang","year":"2020","journal-title":"Thromb. Res."},{"issue":"3","key":"10.1016\/j.thromres.2024.01.017_bb0070","first-page":"453","article-title":"Population pharmacokinetics and pharmacodynamics of once- and twice-daily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement","volume":"100","author":"Mueck","year":"2008","journal-title":"Thromb. Haemost."},{"issue":"23","key":"10.1016\/j.thromres.2024.01.017_bb0075","doi-asserted-by":"crossref","first-page":"456","DOI":"10.21037\/atm.2018.11.24","article-title":"Effects of pre-analytical storage time, temperature, and freeze-thaw times on coagulation factors activities in citrate-anticoagulated plasma","volume":"6","author":"Zhao","year":"2018","journal-title":"Ann Transl Med."},{"key":"10.1016\/j.thromres.2024.01.017_bb0080","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1016\/j.trac.2016.01.029","article-title":"Mass spectrometry in the therapeutic drug monitoring of direct oral anticoagulants. Useful or useless?","volume":"84","author":"Douxfils","year":"2016","journal-title":"TrAC Trends Anal. Chem."},{"issue":"1\u20132","key":"10.1016\/j.thromres.2024.01.017_bb0085","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1016\/j.jchromb.2008.07.015","article-title":"Determination of rivaroxaban - a novel, oral, direct factor Xa inhibitor - in human plasma by high-performance liquid chromatography-tandem mass spectrometry","volume":"872","author":"Rohde","year":"2008","journal-title":"J. Chromatogr. B Anal. Technol. Biomed. Life Sci."},{"issue":"6","key":"10.1016\/j.thromres.2024.01.017_bb0090","doi-asserted-by":"crossref","first-page":"956","DOI":"10.1016\/j.thromres.2012.09.004","article-title":"Assessment of the impact of rivaroxaban on coagulation assays: laboratory recommendations for the monitoring of rivaroxaban and review of the literature","volume":"130","author":"Douxfils","year":"2012","journal-title":"Thromb. Res."},{"issue":"1","key":"10.1016\/j.thromres.2024.01.017_bb0095","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1111\/ijlh.13342","article-title":"Comprehensive review of the impact of direct oral anticoagulants on thrombophilia diagnostic tests: practical recommendations for the laboratory","volume":"43","author":"Siriez","year":"2021","journal-title":"Int. J. Lab. Hematol."},{"issue":"1","key":"10.1016\/j.thromres.2024.01.017_bb0100","doi-asserted-by":"crossref","first-page":"154","DOI":"10.1160\/TH14-02-0161","article-title":"Influence of dabigatran and rivaroxaban on routine coagulation assays","volume":"113","author":"Van Blerk","year":"2015","journal-title":"A nationwide Belgian survey. Thromb Haemost."},{"issue":"5","key":"10.1016\/j.thromres.2024.01.017_bb0105","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1111\/ijlh.12528","article-title":"Comparison of the effect of the anti-Xa direct oral anticoagulants apixaban, edoxaban, and rivaroxaban on coagulation assays","volume":"38","author":"Gosselin","year":"2016","journal-title":"Int. J. Lab. Hematol."},{"issue":"1","key":"10.1016\/j.thromres.2024.01.017_bb0110","first-page":"156","article-title":"Rivaroxaban differentially influences ex vivo global coagulation assays based on the administration time","volume":"106","author":"Mani","year":"2011","journal-title":"Thromb. Haemost."},{"issue":"5\u20136","key":"10.1016\/j.thromres.2024.01.017_bb0115","doi-asserted-by":"crossref","first-page":"423","DOI":"10.3109\/07853890.2013.801274","article-title":"Laboratory testing of rivaroxaban in routine clinical practice: when, how, and which assays","volume":"45","author":"Lindhoff-Last","year":"2013","journal-title":"Ann. Med."},{"issue":"8","key":"10.1016\/j.thromres.2024.01.017_bb0120","doi-asserted-by":"crossref","first-page":"1269","DOI":"10.1002\/rth2.12443","article-title":"Effect of anticoagulants on fibrin clot structure: a comparison between vitamin K antagonists and factor Xa inhibitors","volume":"4","author":"Gauer","year":"2020","journal-title":"Res Pract Thromb Haemost."},{"issue":"3","key":"10.1016\/j.thromres.2024.01.017_bb0125","doi-asserted-by":"crossref","first-page":"292","DOI":"10.1016\/j.pathol.2018.11.008","article-title":"Laboratory testing for lupus anticoagulant (LA) in patients taking direct oral anticoagulants (DOACs): potential for false positives and false negatives","volume":"51","author":"Favaloro","year":"2019","journal-title":"Pathology"},{"issue":"12","key":"10.1016\/j.thromres.2024.01.017_bb0130","doi-asserted-by":"crossref","first-page":"1680","DOI":"10.5858\/arpa.2013-0750-OA","article-title":"Comparison of anti-Xa and dilute Russell viper venom time assays in quantifying drug levels in patients on therapeutic doses of rivaroxaban","volume":"138","author":"Gosselin","year":"2014","journal-title":"Arch. Pathol. Lab. Med."},{"key":"10.1016\/j.thromres.2024.01.017_bb0135","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1016\/j.thromres.2017.06.034","article-title":"An optimized dRVVT-based assay to estimate the intensity of anticoagulation in patients treated with direct oral anticoagulants","volume":"157","author":"Sennesael","year":"2017","journal-title":"Thromb. Res."},{"issue":"5","key":"10.1016\/j.thromres.2024.01.017_bb0140","doi-asserted-by":"crossref","first-page":"852","DOI":"10.1016\/j.thromres.2015.02.020","article-title":"Does the Russell Viper Venom time test provide a rapid estimation of the intensity of oral anticoagulation?","volume":"135","author":"Douxfils","year":"2015","journal-title":"A cohort study. Thromb Res."},{"issue":"8","key":"10.1016\/j.thromres.2024.01.017_bb0145","doi-asserted-by":"crossref","first-page":"1866","DOI":"10.1111\/jth.14829","article-title":"Unveiling the complex effects of direct oral anticoagulants on dilute Russell\u2019s viper venom time assays","volume":"18","author":"Hillarp","year":"2020","journal-title":"J. Thromb. Haemost."},{"issue":"6","key":"10.1016\/j.thromres.2024.01.017_bb0150","doi-asserted-by":"crossref","first-page":"567","DOI":"10.1111\/ejh.13050","article-title":"Screening test for direct oral anticoagulants with the dilute Russell viper venom time","volume":"100","author":"Pratt","year":"2018","journal-title":"Eur. J. Haematol."},{"key":"10.1016\/j.thromres.2024.01.017_bb0155","doi-asserted-by":"crossref","first-page":"1626","DOI":"10.1111\/jth.14158","article-title":"The fibrinogen prothrombin time-derived method is not useful in patients anticoagulated with low molecular weight heparins or rivaroxaban","volume":"16","author":"Duboscq","year":"2018","journal-title":"J. Thromb. Haemost."},{"issue":"1","key":"10.1016\/j.thromres.2024.01.017_bb0160","doi-asserted-by":"crossref","first-page":"60","DOI":"10.1016\/j.pathol.2015.11.025","article-title":"The effect of the direct factor Xa inhibitors apixaban and rivaroxaban on haemostasis tests: a comprehensive assessment using in vitro and ex vivo samples","volume":"48","author":"Bonar","year":"2016","journal-title":"Pathology"},{"issue":"Suppl. 1","key":"10.1016\/j.thromres.2024.01.017_bb0165","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1111\/ijlh.13196","article-title":"The effect of DOACs on laboratory tests and their removal by activated carbon to limit interference in functional assays","volume":"42","author":"Exner","year":"2020","journal-title":"Int. J. Lab. Hematol."},{"issue":"2","key":"10.1016\/j.thromres.2024.01.017_bb0170","doi-asserted-by":"crossref","first-page":"354","DOI":"10.1111\/hae.13930","article-title":"Reducing the effect of DOAC interference in laboratory testing for factor VIII and factor IX: a comparative study using DOAC Stop and andexanet alfa to neutralize rivaroxaban effects","volume":"26","author":"Favaloro","year":"2020","journal-title":"Haemophilia"},{"issue":"8","key":"10.1016\/j.thromres.2024.01.017_bb0175","doi-asserted-by":"crossref","first-page":"1576","DOI":"10.1111\/jth.13747","article-title":"Accuracy and consistency of anti-Xa activity measurement for determination of rivaroxaban plasma levels","volume":"15","author":"Studt","year":"2017","journal-title":"J. Thromb. Haemost."},{"issue":"2","key":"10.1016\/j.thromres.2024.01.017_bb0180","doi-asserted-by":"crossref","first-page":"394","DOI":"10.1016\/j.thromres.2014.11.017","article-title":"Comparison of methods to determine rivaroxaban anti-factor Xa activity","volume":"135","author":"Rathbun","year":"2015","journal-title":"Thromb. Res."},{"issue":"7","key":"10.1016\/j.thromres.2024.01.017_bb0185","doi-asserted-by":"crossref","first-page":"1433","DOI":"10.1111\/j.1538-7836.2012.04784.x","article-title":"Report of the Subcommittee of Control of Anticoagulation on the determination of the anticoagulant effects of rivaroxaban","volume":"10","author":"Harenberg","year":"2012","journal-title":"J. Thromb. Haemost."},{"issue":"4","key":"10.1016\/j.thromres.2024.01.017_bb0190","doi-asserted-by":"crossref","first-page":"493","DOI":"10.1111\/ijlh.12846","article-title":"Measurement of rivaroxaban concentrations demonstrates lack of clinical utility of a PT, dPT and APTT test in estimating levels","volume":"40","author":"Thom","year":"2018","journal-title":"Int. J. Lab. Hematol."},{"issue":"6","key":"10.1016\/j.thromres.2024.01.017_bb0195","doi-asserted-by":"crossref","first-page":"1203","DOI":"10.1111\/bjh.17470","article-title":"A universal anti-Xa assay for rivaroxaban, apixaban, and edoxaban measurements: method validation, diagnostic accuracy and external validation","volume":"193","author":"Willekens","year":"2021","journal-title":"Br. J. Haematol."},{"issue":"11","key":"10.1016\/j.thromres.2024.01.017_bb0200","doi-asserted-by":"crossref","first-page":"2194","DOI":"10.1111\/jth.13486","article-title":"Poor comparability of coagulation screening test with specific measurement in patients receiving direct oral anticoagulants: results from a multicenter\/multiplatform study","volume":"14","author":"Testa","year":"2016","journal-title":"J. Thromb. Haemost."},{"issue":"2","key":"10.1016\/j.thromres.2024.01.017_bb0205","doi-asserted-by":"crossref","DOI":"10.1002\/rth2.12676","article-title":"Lupus anticoagulant testing during anticoagulation, including direct oral anticoagulants","volume":"6","author":"Favaloro","year":"2022","journal-title":"Res Pract Thromb Haemost."},{"issue":"4","key":"10.1016\/j.thromres.2024.01.017_bb0210","doi-asserted-by":"crossref","first-page":"O171","DOI":"10.1111\/ijlh.13487","article-title":"The effect of DOAC-Stop\u00ae on several oral and parenteral anticoagulants","volume":"43","author":"Riva","year":"2021","journal-title":"Int. J. Lab. Hematol."},{"issue":"S1","key":"10.1016\/j.thromres.2024.01.017_bb0215","first-page":"139","article-title":"A rapid, practical and ergonomic device to prepare plasma sample free of platelets and direct oral anticoagulant for routine hemostasis tests","volume":"3","author":"Gheldof","year":"2019","journal-title":"Res Pract Thromb Haemost."},{"issue":"5","key":"10.1016\/j.thromres.2024.01.017_bb0220","doi-asserted-by":"crossref","first-page":"665","DOI":"10.5858\/arpa.2014-0170-OA","article-title":"Use of thromboelastography (TEG) for detection of new oral anticoagulants","volume":"139","author":"Dias","year":"2015","journal-title":"Arch. Pathol. Lab. Med."}],"container-title":["Thrombosis Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0049384824000173?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0049384824000173?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,9,24]],"date-time":"2025-09-24T17:52:10Z","timestamp":1758736330000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0049384824000173"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3]]},"references-count":44,"alternative-id":["S0049384824000173"],"URL":"https:\/\/doi.org\/10.1016\/j.thromres.2024.01.017","relation":{},"ISSN":["0049-3848"],"issn-type":[{"value":"0049-3848","type":"print"}],"subject":[],"published":{"date-parts":[[2024,3]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"A comparative in vitro study of the anticoagulant effect of branded versus generic rivaroxaban","name":"articletitle","label":"Article Title"},{"value":"Thrombosis Research","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.thromres.2024.01.017","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2024 The Authors. Published by Elsevier Ltd.","name":"copyright","label":"Copyright"}]}}