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. |
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| 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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| ISSN: | 1550-7416 |
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| DOI: | 10.1208/s12248-024-00993-9 |
