Confirmatory cut point has limited ability to make accurate classifications in immunogenicity assays

Competitive inhibition with excess unlabeled drug is used to confirm the presence of antidrug antibodies (ADA) in study samples. We evaluated specific and nonspecific responses from both drug-naive and drug-treated subjects to identify conditions required by the confirmatory assay to make accurate A...

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Veröffentlicht in:	Bioanalysis 2020-02, Vol.12 (4), p.245-256
Hauptverfasser:	Kubiak, Robert J, Arends, Rosalinda Hgp, Lee, Nancy, Liang, Meina, Zhang, Jianchun, Roskos, Lorin K
Format:	Artikel
Sprache:	eng
Schlagworte:	Antibodies antidrug antibodies confirmatory cut point Drug dosages Immunogenicity Medical research specific and nonspecific binding
Online-Zugang:	Volltext
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