Development and validation of an ELISA method for the quantification of nivolumab in plasma from non-small-cell lung cancer patients

Alicja Puszkiel,Gaëlle Noé,Pascaline Boudou-Rouquette, Chloé Le- Cossec,Jennifer Arrondeau,Jean-Stephane Giraud,Audrey Thomas-Schoemann, Jérôme Alexandre,Michel Vidal,François Goldwasser,Benoit Blanchet

Journal of Pharmaceutical and Biomedical Analysis（2017）

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摘要

•This study describes a sensitive and accurate ELISA method for quantification of nivolumab in human plasma.•Plasma concentration of nivolumab was assayed in non-small-cell lung cancer patients.•The assay is applicable to investigate pharmacokinetics of nivolumab and its PK/PD relationship.•Endogenous IgG level contributes to the interindvidual variability in nivolumab pharmacokinetics.

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ALP,ALT,AST,BSA,CRP,CV,ECOG,EMA,FDA,IgG4,QC,LC/MS,LDH,LLOQ,LOD,mAb,MRD,NSCLC,nSMOL,OD,PBS,PD-1,PD-L1,PK/PD,SD,ULOQ

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