Evaluating and Reporting the Immunogenicity Impacts for Biological Products--a Clinical Pharmacology Perspective (Q36653930)

15 August 2017

Evaluating and Reporting the Immunogenicity Impacts for Biological Products--a Clinical Pharmacology Perspective (English)

1 reference

15 August 2017

1 reference

Yow-Ming C Wang

1

1 reference

15 August 2017

Jie Wang

2

1 reference

15 August 2017

Yuen Yi Hon

3

1 reference

15 August 2017

Lin Zhou

4

1 reference

15 August 2017

Lanyan Fang

5

1 reference

15 August 2017

Hae Young Ahn

6

1 reference

15 August 2017

language of work or name

English

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publication date

31 December 2015

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15 August 2017

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15 August 2017

18

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15 August 2017

2

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15 August 2017

395-403

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The effect of antidrug antibodies on the sustainable efficacy of biologic therapies in rheumatoid arthritis: practical consequences

15 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Immunogenicity and PK/PD evaluation in biotherapeutic drug development: scientific considerations for bioanalytical methods and data analysis

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Review article: immunogenicity of anti-TNF biologics in IBD - the role of patient, product and prescriber factors

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Review article: a clinician's guide for therapeutic drug monitoring of infliximab in inflammatory bowel disease.

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Drug monitoring of biologics in inflammatory bowel disease.

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Impact of antibodies to infliximab on clinical outcomes and serum infliximab levels in patients with inflammatory bowel disease (IBD): a meta-analysis

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

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

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Critical Review: Assessment of Interferon-β Immunogenicity in Multiple Sclerosis

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Epoetin-associated pure red cell aplasia: past, present, and future considerations

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Scientific and regulatory considerations on the immunogenicity of biologics

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Bioanalytical method validation: concepts, expectations and challenges in small molecule and macromolecule--a report of PITTCON 2013 symposium

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

A survey of applications of biological products for drug interference of immunogenicity assays

28 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up

20 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Regulatory considerations for development of bioanalytical assays for biotechnology products.

20 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

Detection of low-affinity anti-drug antibodies and improved drug tolerance in immunogenicity testing by Octet® biolayer interferometry

20 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4779104

An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen

20 September 2018

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/26721560

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Development and validation of a homogeneous mobility shift assay for the measurement of infliximab and antibodies-to-infliximab levels in patient serum

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/26721560

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Identifiers

DOI

10.1208/S12248-015-9857-Y

1 reference

Dimensions Publication ID

15 August 2017

0 references

1 reference

15 August 2017

PubMed publication ID

26721560

1 reference