(Q37810157)

23 August 2017

title

Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics (English)

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23 August 2017

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Jean W Lee

1

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23 August 2017

publication date

1 November 2009

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23 August 2017

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23 August 2017

volume

1

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23 August 2017

issue

8

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23 August 2017

page(s)

1461-1474

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Oncogenic pathway signatures in human cancers as a guide to targeted therapies

23 August 2017

cites work

1 reference

https://api.crossref.org/works/10.4155%2FBIO.09.130

Compressing drug development timelines in oncology using phase '0' trials.

21 January 2018

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

21 January 2018

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Bioanalytical method validation for macromolecules in support of pharmacokinetic studies

21 January 2018

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Key elements of bioanalytical method validation for macromolecules

21 January 2018

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https://api.crossref.org/works/10.4155%2FBIO.09.130

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

21 January 2018

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https://api.crossref.org/works/10.4155%2FBIO.09.130

Key elements of bioanalytical method validation for small molecules

21 January 2018

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https://api.crossref.org/works/10.4155%2FBIO.09.130

Fit-for-purpose method development and validation for successful biomarker measurement.

21 January 2018

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https://api.crossref.org/works/10.4155%2FBIO.09.130

Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report.

21 January 2018

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https://api.crossref.org/works/10.4155%2FBIO.09.130

Validation of analytic methods for biomarkers used in drug development

21 January 2018

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https://api.crossref.org/works/10.4155%2FBIO.09.130

Biomarker method validation in anticancer drug development

21 January 2018

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https://api.crossref.org/works/10.4155%2FBIO.09.130

Biomarker qualification pilot process at the US Food and Drug Administration

21 January 2018

1 reference

https://api.crossref.org/works/10.4155%2FBIO.09.130

Strategic paths for biomarker qualification

21 January 2018

1 reference

https://api.crossref.org/works/10.4155%2FBIO.09.130

Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples

21 January 2018

1 reference

https://api.crossref.org/works/10.4155%2FBIO.09.130

Preanalytical influences in clinical proteomic studies: raising awareness of fundamental issues in sample banking.

21 January 2018

1 reference

https://api.crossref.org/works/10.4155%2FBIO.09.130

Impact of preanalytical variables on the analysis of biological fluids in proteomic studies.

21 January 2018

1 reference

https://api.crossref.org/works/10.4155%2FBIO.09.130

Tartrate-resistant acid phosphatase (TRACP 5b): a biomarker of bone resorption rate in support of drug development: modification, validation and application of the BoneTRAP kit assay.

21 January 2018

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Standardizing cancer biomarkers criteria: data elements as a foundation for a database. Inflammatory mediator/M-CSF as model marker

21 January 2018

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https://api.crossref.org/works/10.4155%2FBIO.09.130

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

21 January 2018

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https://api.crossref.org/works/10.4155%2FBIO.09.130

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

21 January 2018

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Quantification of recombinant human parathyroid hormone (rhPTH(1-84)) in human plasma by immunoassay: commercial kit evaluation and validation to support pharmacokinetic studies.

21 January 2018

1 reference

https://api.crossref.org/works/10.4155%2FBIO.09.130

Absolute quantification of the model biomarker prostate-specific antigen in serum by LC-Ms/MS using protein cleavage and isotope dilution mass spectrometry

21 January 2018

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Development of a method for the sensitive and quantitative determination of hepcidin in human serum using LC-MS/MS.

21 January 2018

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https://api.crossref.org/works/10.4155%2FBIO.09.130

Mass spectrometry-based hepcidin measurements in serum and urine: analytical aspects and clinical implications

21 January 2018

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A mechanism-based binding model for the population pharmacokinetics and pharmacodynamics of omalizumab.

21 January 2018

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VEGF Trap complex formation measures production rates of VEGF, providing a biomarker for predicting efficacious angiogenic blockade

21 January 2018

1 reference

https://api.crossref.org/works/10.4155%2FBIO.09.130

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

21 January 2018

1 reference

https://api.crossref.org/works/10.4155%2FBIO.09.130

Appropriate calibration curve fitting in ligand binding assays

21 January 2018

1 reference

https://api.crossref.org/works/10.4155%2FBIO.09.130

Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug development: bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor kappaB ligand

21 January 2018

1 reference

https://api.crossref.org/works/10.4155%2FBIO.09.130

Development of recombinant-based mass spectrometric immunoassay with application to resistin expression profiling

21 January 2018

1 reference

https://api.crossref.org/works/10.4155%2FBIO.09.130

21 January 2018

Identifiers

DOI

10.4155/BIO.09.130

1 reference

release_cm2a2sdc2zgdpoja5cdpcyr7by

23 August 2017

Fatcat ID

1 reference

Fatcat

https://api.fatcat.wiki/v0/release/cm2a2sdc2zgdpoja5cdpcyr7by

mapped directly with Wikidata item

24 November 2022

based on heuristic

1 reference