PK-PD modeling of protein drugs: implications in assay development.
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Receptor occupancy assessment by flow cytometry as a pharmacodynamic biomarker in biopharmaceutical developmentImmunogenicity and PK/PD evaluation in biotherapeutic drug development: scientific considerations for bioanalytical methods and data analysis.A white paper--consensus and recommendations of a global harmonization team on assessing the impact of immunogenicity on pharmacokinetic measurements.Characterization of a quantitative method to measure free proprotein convertase subtilisin/kexin type 9 in human serum.Evaluation of assay interference and interpretation of CXCR4 receptor occupancy results in a preclinical study with MEDI3185, a fully human antibody to CXCR4Life cycle management of critical ligand-binding reagents.Analytical assay platforms for soluble target engagement biomarkers: old favorites and emerging technologies.Biomarkers: refining diagnosis and expediting drug development - reality, aspiration and the role of open innovation.A systematic review of the pharmacokinetic and pharmacodynamic interactions of herbal medicine with warfarin.Impact of Shed/Soluble targets on the PK/PD of approved therapeutic monoclonal antibodies.Validation of a ligand-binding assay for active protein drug quantification following the 'free analyte QC concept'.Multiplexing of receptor occupancy measurements for pharmacodynamic biomarker assessment of biopharmaceuticals.Insights into antibody-drug conjugates: bioanalysis and biomeasures in discovery.Free analyte QC concept: a novel approach to prove correct quantification of free therapeutic protein drug/biomarker concentrations.Mathematical simulations for bioanalytical assay development: the (un-)necessity and (im-)possibility of free drug quantification.Immunoaffinity LC-MS/MS for quantitative determination of a free and total protein target as a target engagement biomarker.Quantification of a bifunctional drug in the presence of an immune response: a ligand-binding assay specific for 'active' drug.
P2860
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P2860
PK-PD modeling of protein drugs: implications in assay development.
description
article científic
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article scientifique
@fr
articolo scientifico
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artigo científico
@pt
bilimsel makale
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scientific article published on March 2011
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vedecký článok
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vetenskaplig artikel
@sv
videnskabelig artikel
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vědecký článek
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name
PK-PD modeling of protein drugs: implications in assay development.
@en
PK-PD modeling of protein drugs: implications in assay development.
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type
label
PK-PD modeling of protein drugs: implications in assay development.
@en
PK-PD modeling of protein drugs: implications in assay development.
@nl
prefLabel
PK-PD modeling of protein drugs: implications in assay development.
@en
PK-PD modeling of protein drugs: implications in assay development.
@nl
P2093
P2860
P356
P1433
P1476
PK-PD modeling of protein drugs: implications in assay development.
@en
P2093
Amy Schneider
Inna Vainshtein
Lorin K Roskos
Martin Schwickart
Meina Liang
Raffaella Faggioni
Rozanne Lee
P2860
P304
P356
10.4155/BIO.11.28
P577
2011-03-01T00:00:00Z