Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling

Liang Zhu,Ying Wang,Alison Joyce,Ihor Djura,Boris Gorovits

Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling

2019

Liang Zhu
Ying Wang
Alison Joyce
Ihor Djura
Boris Gorovits

Purpose The purpose of this study was to validate a ligand binding assay for the quantitation of a monoclonal antibody-based biotherapeutics (PF-57781346) in samples collected via capillary microsampling to support a regulated mouse toxicity study.

Keywords:

Ligand binding assay
Chemistry
Monoclonal antibody
Biochemistry
Toxicokinetics
Toxicity
Chromatography
Bioanalysis
sample processing
Whole blood
Matrix (chemical analysis)
serial sampling
Accuracy and precision

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