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. |
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| 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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| ISSN: | 1550-7416 |
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| DOI: | 10.1208/s12248-023-00806-5 |
