A survey of pharmacokinetic bioanalytical methods in biosimilar biological license applications for the assessment of target and antidrug antibody effects

The presence of circulating targets and antidrug antibodies can influence the ability of a bioanalytical method to measure therapeutic protein (TP) concentration relevant to exposure-response evaluations. This project surveyed biosimilar submissions for their bioanalytical methods. Survey results re...

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Veröffentlicht in:	Bioanalysis 2021-09, Vol.13 (17), p.1323-1332
Hauptverfasser:	Hackel, Dana T, Thway, Theingi M, Huang, Shiew Mei, Wang, Yow-Ming C
Format:	Artikel
Sprache:	eng
Schlagworte:	Antibodies - immunology Biosimilar Pharmaceuticals - therapeutic use biosimilars BLA clinical Drug Discovery - methods Humans matrix effects method development
Online-Zugang:	Volltext
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