"Fit-for-purpose" method validation and application of a biomarker (C-terminal telopeptides of type 1 collagen) in denosumab clinical studies - Test2 - elhamkhani - TriplyDB

"Fit-for-purpose" method validation and application of a biomarker (C-terminal telopeptides of type 1 collagen) in denosumab clinical studies

"Fit-for-purpose" method validation and application of a biomarker (C-terminal telopeptides of type 1 collagen) in denosumab clinical studies

http://www.wikidata.org/entity/Q37214552

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Long-term treatment of osteoporosis: safety and efficacy appraisal of denosumab Characterization 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.

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"Fit-for-purpose" method validation and application of a biomarker (C-terminal telopeptides of type 1 collagen) in denosumab clinical studies

http://www.wikidata.org/entity/Q37214552

description

article científic

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article scientifique

@fr

articolo scientifico

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artigo científico

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bilimsel makale

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scientific article published on 22 May 2009

@en

vedecký článok

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vetenskaplig artikel

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videnskabelig artikel

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vědecký článek

@cs

name

"Fit-for-purpose" method valid ...... in denosumab clinical studies

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"Fit-for-purpose" method validation and application of a biomarker

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type

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"Fit-for-purpose" method valid ...... in denosumab clinical studies

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"Fit-for-purpose" method validation and application of a biomarker

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"Fit-for-purpose" method valid ...... in denosumab clinical studies

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"Fit-for-purpose" method validation and application of a biomarker

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S12248-009-9115-2

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The AAPS Journal

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"Fit-for-purpose" method valid ...... in denosumab clinical studies

@en

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Binodh DeSilva

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Daniel Burns

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David Doherty

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Jean Lee

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Jin Wang

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Laura Brunner

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Mark Peterson

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Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective.

Markers of bone turnover for monitoring treatment of osteoporosis with antiresorptive drugs.

Biomarkers, validation and pharmacokinetic-pharmacodynamic modelling.

Biochemical markers of bone turnover in the clinical development of drugs for osteoporosis and metastatic bone disease: potential uses and pitfalls.

Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays.

Method validation of protein biomarkers in support of drug development or clinical diagnosis/prognosis.

Specificity and selectivity evaluations of ligand binding assay of protein therapeutics against concomitant drugs and related endogenous proteins.

A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women.

Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules.

Serum CrossLaps for monitoring the response in individuals undergoing antiresorptive therapy.

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s12248-009-9115-2

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385-394

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scholarly article

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10.1208/S12248-009-9115-2

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2

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2009-05-22T00:00:00Z

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24446334

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1015449798

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19462251

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2691475

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