The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays

The European Bioanalysis Forum, in collaboration with several key industry stakeholders, has recently led discussions that address international immunogenicity guidance documents, specifically the three tier approach for immunogenicity testing strategies, after more than 20 years of experience with...

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Veröffentlicht in:	Bioanalysis 2024-09, Vol.16 (17-18), p.915-921
Hauptverfasser:	Cowan, Kyra J, Champion, Lysie, Dyer, Daniel, Carlsen, Morten Funch, Geary, Laura, Genin, Jean-Christophe, Golob, Michaela, Goodman, Joanne, Kromminga, Arno, Nelson, Rob, Revell, Heather, Rieger, Martin, Van de Vyver, Ortwin, Venema, Foka, Timmerman, Philip
Format:	Artikel
Sprache:	eng
Schlagworte:	Antibodies - immunology Drug Tolerance Europe Humans Pharmaceutical Preparations - analysis
Online-Zugang:	Volltext
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