(Q41861047)

13 October 2017

0 references

Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment (English)

1 reference

13 October 2017

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1 reference

Marian Kelley

1

1 reference

13 October 2017

Lauren Stevenson

2

1 reference

13 October 2017

Michaela Golob

3

1 reference

13 October 2017

Viswanath Devanarayan

4

1 reference

13 October 2017

Joao Pedras-Vasconcelos

5

1 reference

13 October 2017

Roland F Staack

6

1 reference

13 October 2017

Rand Jenkins

7

1 reference

13 October 2017

Brian Booth

8

1 reference

13 October 2017

Eric Wakshull

9

1 reference

13 October 2017

Ronald Bowsher

10

1 reference

13 October 2017

Marie Rock

11

1 reference

13 October 2017

Sherri Dudal

12

1 reference

13 October 2017

Binodh DeSilva

13

1 reference

13 October 2017

language of work or name

English

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publication date

30 April 2015

1 reference

13 October 2017

1 reference

13 October 2017

17

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13 October 2017

4

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13 October 2017

1019-1024

1 reference

Workshop report: Crystal City V--quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance

13 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4476978

Bioanalytical approaches to quantify "total" and "free" therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development

5 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4476978

Appropriate calibration curve fitting in ligand binding assays

5 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4476978

Key elements of bioanalytical method validation for macromolecules

5 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4476978

Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics

5 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4476978

Free analyte QC concept: a novel approach to prove correct quantification of free therapeutic protein drug/biomarker concentrations

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4476978

Mathematical simulations for bioanalytical assay development: the (un-)necessity and (im-)possibility of free drug quantification

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4476978

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

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4476978

10.1208/S12248-015-9767-Z

18 August 2018

Identifiers

DOI

1 reference

Dimensions Publication ID

13 October 2017

0 references

1 reference

13 October 2017

PubMed publication ID

25921938

1 reference