{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T19:46:17Z","timestamp":1793907977419,"version":"4.8.0"},"reference-count":24,"publisher":"Informa UK Limited","issue":"5-6","license":[{"start":{"date-parts":[[2026,4,13]],"date-time":"2026-04-13T00:00:00Z","timestamp":1776038400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,4,13]],"date-time":"2026-04-13T00:00:00Z","timestamp":1776038400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/doi.org\/10.1080\/policies-text-data-mining"}],"funder":[{"DOI":"10.13039\/100030833","name":"Syneos Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100030833","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.tandfonline.com"],"crossmark-restriction":true},"short-container-title":["Bioanalysis"],"published-print":{"date-parts":[[2026,4,13]]},"DOI":"10.1080\/17576180.2026.2674992","type":"journal-article","created":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T12:56:57Z","timestamp":1779195417000},"page":"457-465","update-policy":"https:\/\/doi.org\/10.1080\/tandf_crossmark_01","source":"Crossref","is-referenced-by-count":1,"title":["Method qualification of an electrochemiluminescence assay to quantitate anti-Fc\u03b5R1\u03b1 autoantibodies: a case study of an antibody-based biomarker"],"prefix":"10.1080","volume":"18","author":[{"given":"Matthew J.","family":"Lawless","sequence":"first","affiliation":[{"name":"Syneos Health US Inc","place":["Princeton, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikki","family":"Chan","sequence":"additional","affiliation":[{"name":"Syneos Health US Inc","place":["Princeton, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kruti","family":"Patel","sequence":"additional","affiliation":[{"name":"Syneos Health US Inc","place":["Princeton, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonika","family":"Mudiyala","sequence":"additional","affiliation":[{"name":"Syneos Health US Inc","place":["Princeton, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"301","published-online":{"date-parts":[[2026,5,19]]},"reference":[{"key":"e_1_3_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.13414"},{"key":"e_1_3_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.14037"},{"key":"e_1_3_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.15603"},{"key":"e_1_3_8_5_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2019.00627"},{"key":"e_1_3_8_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199306033282204"},{"key":"e_1_3_8_7_1","doi-asserted-by":"publisher","DOI":"10.1155\/2022\/6863682"},{"key":"e_1_3_8_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.14412"},{"key":"e_1_3_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/cei.13428"},{"key":"e_1_3_8_10_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0273415"},{"key":"e_1_3_8_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-021-01537-w"},{"key":"e_1_3_8_12_1","doi-asserted-by":"publisher","DOI":"10.4155\/bio.09.80"},{"key":"e_1_3_8_13_1","unstructured":"FDA. Focus area: biomarkers: FDA. 2022. Available from: https:\/\/www.fda.gov\/science-research\/focus-areas-regulatory-science-report\/focus-area-biomarkers#:%E2%88%BC:text=Biomarkers%20are%20characteristics%20that%20are or%20intervention%2C%20including%20therapeutic%20interventions"},{"key":"e_1_3_8_14_1","unstructured":"FDA. Bioanalytical method validation for biomarkers: guidance for industry. Silver Spring (MD); 2026. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/bioanalytical-method-validation-biomarkers"},{"key":"e_1_3_8_15_1","volume-title":"M10 Bioanalytical method validation and study sample analysis","author":"ICH","year":"2022","unstructured":"ICH. M10 Bioanalytical method validation and study sample analysis. Research CfDEa, editor. Silver Spring (MD): FDA; 2022."},{"key":"e_1_3_8_16_1","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2020.01081"},{"key":"e_1_3_8_17_1","doi-asserted-by":"publisher","DOI":"10.14309\/ctg.0000000000000284"},{"key":"e_1_3_8_18_1","unstructured":"FDA. Immunogenicity testing of therapeutic protein products - developing and validating assays for ANti-drug antibody detection. Silver Spring (MD); 2019. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/immunogenicity-testing-therapeutic-protein-products-developing-and-validating-assays-anti-drug"},{"key":"e_1_3_8_19_1","doi-asserted-by":"publisher","DOI":"10.1080\/10543406.2014.979196"},{"key":"e_1_3_8_20_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-020-03225-5"},{"key":"e_1_3_8_21_1","doi-asserted-by":"publisher","DOI":"10.1515\/cclm-2015-1195"},{"key":"e_1_3_8_22_1","doi-asserted-by":"publisher","DOI":"10.4155\/bio-2017-0284"},{"key":"e_1_3_8_23_1","doi-asserted-by":"publisher","DOI":"10.4155\/bio-2017-0084"},{"key":"e_1_3_8_24_1","unstructured":"Administration UFaD. Guidance for industry: immunogenicity assessment for therapuetic protein products. 2014."},{"key":"e_1_3_8_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jim.2015.02.004"}],"container-title":["Bioanalysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.tandfonline.com\/doi\/pdf\/10.1080\/17576180.2026.2674992","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.tandfonline.com\/doi\/full-xml\/10.1080\/17576180.2026.2674992","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.tandfonline.com\/doi\/pdf\/10.1080\/17576180.2026.2674992","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T12:04:40Z","timestamp":1782216280000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/17576180.2026.2674992"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,13]]},"references-count":24,"journal-issue":{"issue":"5-6","published-print":{"date-parts":[[2026,4,13]]}},"alternative-id":["10.1080\/17576180.2026.2674992"],"URL":"https:\/\/doi.org\/10.1080\/17576180.2026.2674992","relation":{},"ISSN":["1757-6180","1757-6199"],"issn-type":[{"value":"1757-6180","type":"print"},{"value":"1757-6199","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,13]]},"assertion":[{"value":"The publishing and review policy for this title is described in its Aims & Scope.","order":1,"name":"peerreview_statement","label":"Peer Review Statement"},{"value":"http:\/\/www.tandfonline.com\/action\/journalInformation?show=aimsScope&journalCode=ibio20","URL":"http:\/\/www.tandfonline.com\/action\/journalInformation?show=aimsScope&journalCode=ibio20","order":2,"name":"aims_and_scope_url","label":"Aim & Scope"},{"value":"2026-01-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-12","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}