Large molecule specific assay operation: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team.
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Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development.Plasma neurofilament heavy chain levels and disease progression in amyotrophic lateral sclerosis: insights from a longitudinal study.Parallelism experiments to evaluate matrix effects, selectivity and sensitivity in ligand-binding assay method development: pros and cons.Bypassing nonparallelism of a monoclonal antibody ligand-binding assay by employment of alternative assay formats.Calculations for Adjusting Endogenous Biomarker Levels During Analytical Recovery Assessments for Ligand-Binding Assay Bioanalytical Method Validation.Introduction to the proposals from the global bioanalysis consortium harmonization team.Current practices and future outlook on the integration of biomarkers in the drug development process.Japanese bioanalytical method validation guideline: the world's first regulatory guideline dedicated to ligand-binding assays.Orthogonal tools to help determine the required selectivity of ligand-binding assays in drug development.
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Q28081875-BF267004-1EB3-40D5-8B53-3A3619D5C9C8Q35550715-0ECAFC84-1980-40F5-8ED7-B94E45B99813Q38665209-F946A17A-9554-4E92-99BD-B32DCD8D9A30Q39156341-A39B1CF4-543E-46C8-ABF5-F3B4F830D4F5Q42411948-07173481-C377-4F62-BAF9-963ED1C605C1Q43224025-C83207A8-BB73-4740-9888-4884AAC5F1CCQ47626694-3A70730F-A533-442D-8B4C-9F1531B08086Q50909443-256039E8-673E-4DCE-BC53-CF894DFF4506Q53281208-0077C531-37A5-4D03-B897-0412CE005DC5
P2860
Large molecule specific assay operation: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team.
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Large molecule specific assay ...... consortium harmonization team.
@en
Large molecule specific assay ...... consortium harmonization team.
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Large molecule specific assay ...... consortium harmonization team.
@en
Large molecule specific assay ...... consortium harmonization team.
@nl
prefLabel
Large molecule specific assay ...... consortium harmonization team.
@en
Large molecule specific assay ...... consortium harmonization team.
@nl
P2093
P2860
P1433
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Large molecule specific assay ...... consortium harmonization team.
@en
P2093
Arumugam Muruganandam
Boris Gorovits
Clare Kingsley
Heather Myler
Karolina Osterlund
Lauren Stevenson
Marian Kelley
Mario Dominguez
Yoshiyuki Minamide
P2860
P2888
P356
10.1208/S12248-013-9542-Y
P407
P577
2013-11-16T00:00:00Z
P6179
1034129783