"Fit-for-purpose" method validation and application of a biomarker (C-terminal telopeptides of type 1 collagen) in denosumab clinical studies
about
Long-term treatment of osteoporosis: safety and efficacy appraisal of denosumabCharacterization of a quantitative method to measure free proprotein convertase subtilisin/kexin type 9 in human serum.COPD association and repeatability of blood biomarkers in the ECLIPSE cohort.When close is not close enough: a comparison of endogenous and recombinant biomarker stability samples.Quantitative hydrophilic interaction chromatography-mass spectrometry analysis of N-acetylneuraminic acid and N-acetylmannosamine in human plasma.Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics.Systematic analytical validation of commercial kits for the determination of novel biomarkers for clinical drug development.Biotherapeutic bioanalysis: a multi-indication case study review.Bioanalysis of target biomarker and PK/PD relevancy during the development of biotherapeutics.Current industrial practices and regulatory requirements to assess analyte and reagent stability using ligand-binding assays.Validation of a ligand binding assay using dried blood spot sampling.Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development.Calculations for Adjusting Endogenous Biomarker Levels During Analytical Recovery Assessments for Ligand-Binding Assay Bioanalytical Method Validation.Laboratory automation of high-quality and efficient ligand-binding assays for biotherapeutic drug development.Stability assessment in ligand-binding assays: a critical parameter for data integrity.A generic template for automated bioanalytical ligand-binding assays using modular robotic scripts in support of discovery biotherapeutic programs.Addressing the challenges of biomarker calibration standards in ligand-binding assays: a European Bioanalysis Forum perspective.The application of control charts in regulated bioanalysis for monitoring long-term reproducibility.A novel, high-sensitivity and drug-tolerant sandwich immunoassay for the quantitative measurement of circulating proteins.
P2860
Q28727655-B85CD011-704C-40C5-9B0A-4AF767A1B9B8Q34223925-0CFC412C-E83F-45BA-8F27-57E0F89A9D9AQ35637295-53A1DAF8-47C8-4DB3-A9BC-7A64C6C414BEQ35674203-18499268-EC30-4137-BE66-310FF7C28C8AQ35981675-FEBC1DA1-526F-4030-BDDD-F0D2295AA7BDQ37810157-8DFC10E6-616A-475C-B540-6DAFD0CC9AB4Q37810247-3EE46E0E-FB0F-4BAF-902C-08C91EE56DA8Q37854629-2FA06C08-3314-478C-8A7C-0C7A232C7CEEQ38060204-BD8A99CA-CEAA-4025-B987-F7086550AB49Q38537695-4D64B882-1474-4FF4-83AC-6049267EE411Q39523488-9EED88F3-3872-4960-A8CE-6D16592B5E4EQ41584061-AE7AB931-3A73-41FA-B99F-8ED34A0B1456Q42411948-D8E844D7-1D10-4D2B-AE96-0035DDC62CE7Q42607030-6B3EEB40-7B40-4FC8-A667-6EAB6966BE62Q44702609-905BC916-C7A8-4D07-A078-C27965F7E134Q44767432-D297D429-FBA5-4E15-BED0-2C2170BAFA7BQ47748457-4893B716-7E47-4D83-89E3-48F8A8754000Q49909213-E7800A3C-016B-4966-B279-4533D49C03F7Q53671100-B228129C-59E3-4BCC-8358-E2BCF49B29D7
P2860
"Fit-for-purpose" method validation and application of a biomarker (C-terminal telopeptides of type 1 collagen) in denosumab clinical studies
description
article científic
@ca
article scientifique
@fr
articolo scientifico
@it
artigo científico
@pt
bilimsel makale
@tr
scientific article published on 22 May 2009
@en
vedecký článok
@sk
vetenskaplig artikel
@sv
videnskabelig artikel
@da
vědecký článek
@cs
name
"Fit-for-purpose" method valid ...... in denosumab clinical studies
@en
"Fit-for-purpose" method validation and application of a biomarker
@nl
type
label
"Fit-for-purpose" method valid ...... in denosumab clinical studies
@en
"Fit-for-purpose" method validation and application of a biomarker
@nl
prefLabel
"Fit-for-purpose" method valid ...... in denosumab clinical studies
@en
"Fit-for-purpose" method validation and application of a biomarker
@nl
P2093
P2860
P1433
P1476
"Fit-for-purpose" method valid ...... in denosumab clinical studies
@en
P2093
Binodh DeSilva
Daniel Burns
David Doherty
Laura Brunner
Mark Peterson
P2860
P2888
P304
P356
10.1208/S12248-009-9115-2
P407
P577
2009-05-22T00:00:00Z
P5875
P6179
1015449798