Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium.

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Title: Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium.
Authors: Starcevic Manning M; Translational Safety and Bioanalytical Sciences, Amgen Research, One Amgen Center Drive, MS 30E-3B, Thousand Oaks, California, 91320, USA. mstarcev@amgen.com., Hassanein M; Early Clinical Development, Precision Medicine, Pfizer Inc., Cambridge, Massachusetts, USA., Partridge MA; Bioanalytical Sciences, Regeneron, Tarrytown, New York, USA., Jawa V; Non-clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA., Mora J; Non-clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA., Ryman J; Quantitative Pharmacology and Pharmacometrics, Merck, Kenilworth, New Jersey, USA., Barker B; Specialty Bioanalytics, Teva Pharmaceuticals, West Chester, Pennsylvania, USA.; Incyte Corporation, Wilmington, Delaware, USA., Braithwaite C; BioAgilytix, Boston, Massachusetts, USA., Carleton K; Janssen Preclinical Safety and Translational Sciences, Spring House, Pennsylvania, USA., Hay L; Bioanalytical Lab, PPD Clinical Research Services, Thermo Fisher Scientific, Richmond, Virginia, USA., Hottenstein C; Bioanalysis, Immunogenicity and Biomarkers, GlaxoSmithKline, Collegeville, Pennsylvania, USA., Kubiak RJ; Clinical Pharmacology and Safety Sciences, AstraZeneca, Gaithersburg, Maryland, USA., Devanarayan V; Data Science, Eisai Inc., Nutley, New Jersey, USA.
Source: The AAPS journal [AAPS J] 2022 Jul 12; Vol. 24 (4), pp. 81. Date of Electronic Publication: 2022 Jul 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
DOI:10.1208/s12248-022-00728-8