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A generic anti-drug antibody assay for monoclonal antibody therapeutics with broad dynamic range eliminates the need for titer evaluation in preclinical studies.

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Title: A generic anti-drug antibody assay for monoclonal antibody therapeutics with broad dynamic range eliminates the need for titer evaluation in preclinical studies.
Authors: Li H; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA. Electronic address: li.amy.al1@gene.com., Foley AR; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA., Shim J; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA., Siradze K; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA., Webb-Vargas Y; Nonclinical Biostatistics, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA., Sperinde G; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA., Fischer SK; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
Source: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2024 Oct 15; Vol. 249, pp. 116364. Date of Electronic Publication: 2024 Jul 15.
Publication Type: Journal Article
Journal Info: Publisher: Elsevier Science Country of Publication: England NLM ID: 8309336 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-264X (Electronic) Linking ISSN: 07317085 NLM ISO Abbreviation: J Pharm Biomed Anal Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: A generic anti-drug antibody assay for monoclonal antibody therapeutics with broad dynamic range eliminates the need for titer evaluation in preclinical studies.
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  Data: <searchLink fieldCode="AU" term="%22Li+H%22">Li H</searchLink>; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA. Electronic address: li.amy.al1@gene.com.<br /><searchLink fieldCode="AU" term="%22Foley+AR%22">Foley AR</searchLink>; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.<br /><searchLink fieldCode="AU" term="%22Shim+J%22">Shim J</searchLink>; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.<br /><searchLink fieldCode="AU" term="%22Siradze+K%22">Siradze K</searchLink>; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.<br /><searchLink fieldCode="AU" term="%22Webb-Vargas+Y%22">Webb-Vargas Y</searchLink>; Nonclinical Biostatistics, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.<br /><searchLink fieldCode="AU" term="%22Sperinde+G%22">Sperinde G</searchLink>; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.<br /><searchLink fieldCode="AU" term="%22Fischer+SK%22">Fischer SK</searchLink>; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
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  Data: <searchLink fieldCode="JN" term="%228309336%22">Journal of pharmaceutical and biomedical analysis</searchLink> [J Pharm Biomed Anal] 2024 Oct 15; Vol. 249, pp. 116364. <i>Date of Electronic Publication: </i>2024 Jul 15.
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      – Type: doi
        Value: 10.1016/j.jpba.2024.116364
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        Text: English
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      – TitleFull: A generic anti-drug antibody assay for monoclonal antibody therapeutics with broad dynamic range eliminates the need for titer evaluation in preclinical studies.
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              Text: 2024 Oct 15
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