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Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials.

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Title: Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials.
Authors: Lai CH; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA. ching-ha.lai@regeneron.com., Chen M; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Fraser S; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Wang J; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., McAfee S; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Speaks E; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Simeone N; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Rodriguez J; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Stefan C; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., DeStefano L; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Elango C; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Andisik MD; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Sumner G; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Zhao A; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Irvin SC; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Torri A; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA., Partridge MA; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.
Source: The AAPS journal [AAPS J] 2024 Dec 12; Vol. 27 (1), pp. 11. Date of Electronic Publication: 2024 Dec 12.
Publication Type: Journal Article; Research Support, Non-U.S. Gov't
Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials.
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  Data: <searchLink fieldCode="AU" term="%22Lai+CH%22">Lai CH</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA. ching-ha.lai@regeneron.com.<br /><searchLink fieldCode="AU" term="%22Chen+M%22">Chen M</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Fraser+S%22">Fraser S</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Wang+J%22">Wang J</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22McAfee+S%22">McAfee S</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Speaks+E%22">Speaks E</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Simeone+N%22">Simeone N</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Rodriguez+J%22">Rodriguez J</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Stefan+C%22">Stefan C</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22DeStefano+L%22">DeStefano L</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Elango+C%22">Elango C</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Andisik+MD%22">Andisik MD</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Sumner+G%22">Sumner G</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Zhao+A%22">Zhao A</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Irvin+SC%22">Irvin SC</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Torri+A%22">Torri A</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.<br /><searchLink fieldCode="AU" term="%22Partridge+MA%22">Partridge MA</searchLink>; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.
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  Data: <searchLink fieldCode="JN" term="%22101223209%22">The AAPS journal</searchLink> [AAPS J] 2024 Dec 12; Vol. 27 (1), pp. 11. <i>Date of Electronic Publication: </i>2024 Dec 12.
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