Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs (Q37798159)

23 August 2017

4 references

19 June 2019

7 August 2019

19 September 2019

14 September 2020

Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs (English)

1 reference

biomedical investigative technique

23 August 2017

0 references

1 reference

7 August 2019

1 reference

19 September 2019

1 reference

14 September 2020

C Dive

5

0 references

Florence Raynaud

object named as

F Raynaud

2

0 references

author name string

J Cummings

1

1 reference

23 August 2017

L Jones

3

1 reference

23 August 2017

R Sugar

4

1 reference

23 August 2017

language of work or name

English

0 references

publication date

5 October 2010

1 reference

British Journal of Cancer

23 August 2017

26 October 2010

4 references

19 June 2019

7 August 2019

19 September 2019

14 September 2020

5 references

23 August 2017

19 June 2019

7 August 2019

19 September 2019

14 September 2020

103

1 reference

23 August 2017

1313-1317

1 reference

23 August 2017

9

1 reference

https://scigraph.springernature.com/pub.10.1038/sj.bjc.6605910

23 August 2017

0 references

cites work

Can molecular biomarker-based patient selection in Phase I trials accelerate anticancer drug development?

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Biomarker-driven early clinical trials in oncology: a paradigm shift in drug development

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Evaluation of circulating tumor cells and serological cell death biomarkers in small cell lung cancer patients undergoing chemotherapy

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Biomarkers of response and resistance to antiangiogenic therapy

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Workshop report and follow-up--AAPS Workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples--implications of Crystal City recommendations

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Effective incorporation of biomarkers into phase II trials

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Phase I trial of AEG35156 administered as a 7-day and 3-day continuous intravenous infusion in patients with advanced refractory cancer

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Some important considerations for validation of ligand-binding assays

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Protein aggregation: pathways, induction factors and analysis

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Biomarker method validation in anticancer drug development

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

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

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

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

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Validation of analytical methods based on accuracy profiles

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Biomarker assay translation from discovery to clinical studies in cancer drug development: quantification of emerging protein biomarkers.

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Pharmacodynamic biomarkers for molecular cancer therapeutics

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Biomarkers in cancer staging, prognosis and treatment selection

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Using tolerance intervals in pre-study validation of analytical methods to predict in-study results. The fit-for-future-purpose concept

14 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Specificity and accuracy data for ligand-binding assays for macromolecules should be interpreted with caution

14 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Key elements of bioanalytical method validation for macromolecules

23 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

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

23 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies

23 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Optimisation of circulating biomarkers of cell death for routine clinical use.

23 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

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

1 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

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

1 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: progress and limitations.

1 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2990602

Qualification of M30 and M65 ELISAs as surrogate biomarkers of cell death: long term antigen stability in cancer patient plasma

1 September 2018

1 reference

Crossref

https://api.crossref.org/works/10.1038%2FSJ.BJC.6605910

Bioanalytical method validation--a revisit with a decade of progress

21 January 2018

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/20924371

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Identifiers

DOI

10.1038/SJ.BJC.6605910

1 reference

23 August 2017

1 reference

23 August 2017

1 reference