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Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal.

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Title: Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal.
Authors: Garlits J; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, New York, 10591, USA., McAfee S; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, New York, 10591, USA., Taylor JA; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, New York, 10591, USA., Shum E; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, New York, 10591, USA., Yang Q; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, New York, 10591, USA.; Kriya Therapeutics, 4105 Hopson Rd, Durham, North Carolina, 27713, USA., Nunez E; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, New York, 10591, USA., Kameron K; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, New York, 10591, USA., Fenech K; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, New York, 10591, USA., Rodriguez J; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, New York, 10591, USA., Torri A; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, New York, 10591, USA., Chen J; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, New York, 10591, USA., Sumner G; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, New York, 10591, USA., Partridge MA; Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, New York, 10591, USA. michael.partridge@regeneron.com.
Source: The AAPS journal [AAPS J] 2023 Apr 04; Vol. 25 (3), pp. 37. Date of Electronic Publication: 2023 Apr 04.
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: Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal.
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  Data: <searchLink fieldCode="JN" term="%22101223209%22">The AAPS journal</searchLink> [AAPS J] 2023 Apr 04; Vol. 25 (3), pp. 37. <i>Date of Electronic Publication: </i>2023 Apr 04.
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