(Q53100427)

English

Validation and life-cycle management of a quantitative ligand-binding assay for the measurement of Nulojix(®), a CTLA-4-Fc fusion protein, in renal and liver transplant patients.

scientific article published in June 2012

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scholarly article

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

Validation and life-cycle management of a quantitative ligand-binding assay for the measurement of Nulojix(®), a CTLA-4-Fc fusion protein, in renal and liver transplant patients. (English)

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

1 reference

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Heather A Myler

1

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

Kelli R Phillips

2

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

Huijin Dong

3

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

Edward Tabler

4

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

Mehmooda Shaikh

5

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

Valarie Coats

6

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

Laura Hay

7

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

Richard Tacey

8

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

Bruce Stouffer

9

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

publication date

1 June 2012

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

4

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

10

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

1215-1226

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective

1 reference

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21 January 2018

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

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

Key elements of bioanalytical method validation for macromolecules

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

Bioanalytical method validation for macromolecules in support of pharmacokinetic studies

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

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1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

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

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

Incurred sample reanalysis: failures in macromolecule analysis--insight into possible causes

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study).

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

Bioanalytical considerations in the comparability assessment of biotherapeutics

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

Ligand binding assays in the 21st century laboratory: recommendations for characterization and supply of critical reagents

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

Critical ligand binding reagent preparation/selection: when specificity depends on reagents

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

Strategies to minimize variability and bias associated with manual pipetting in ligand binding assays to assure data quality of protein therapeutic quantification

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

Biotherapeutic bioanalysis: a multi-indication case study review

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programs

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

Troubleshooting PEG-hGH detection supporting pharmacokinetic evaluation in growth hormone deficient patients

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

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

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

Ligand-binding mass spectrometry to study biotransformation of fusion protein drugs and guide immunoassay development: strategic approach and application to peptibodies targeting the thrombopoietin receptor

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

A sample preparation process for LC-MS/MS analysis of total protein drug concentrations in monkey plasma samples with antibody.

1 reference

https://api.crossref.org/works/10.4155%2FBIO.12.79

21 January 2018

Identifiers

10.4155/BIO.12.79

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

PubMed publication ID

1 reference

Europe PubMed Central

PubMed publication ID

11 May 2018

http://europepmc.org/abstract/MED/22651565

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