Bioanalysis of an antibody drug conjugate (ADC) PYX-201 in human plasma using a hybrid immunoaffinity LC–MS/MS approach

•First LC-MS/MS assay validation on the investigational ADC, PYX–201 was reported.•A hybrid immunoaffinity LC–MS/MS assay was validated for PYX-201 in human plasma.•2018 U.S. FDA guidance and 2022 U.S. FDA ICH M10 guidance for BMV were followed.•PYX-201 was proven stable after various stabilities we...

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Veröffentlicht in:	Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Analytical technologies in the biomedical and life sciences, 2023-05, Vol.1223, p.123715-123715, Article 123715
Hauptverfasser:	Yin, Feng, Adhikari, Diana, Sun, Minghao, Shane Woolf, M., Ma, Eric, Mylott, William, Shaheen, Elizabeth, Harriman, Shawn, Pinkas, Jan
Format:	Artikel
Sprache:	eng
Online-Zugang:	Volltext
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