(Q33804009)

English

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

scientific article

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scholarly article

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

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

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

author name string

G Shankar

1

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

S Arkin

2

1 reference

Europe PubMed Central

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29 July 2017

L Cocea

3

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

V Devanarayan

4

1 reference

Europe PubMed Central

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29 July 2017

S Kirshner

5

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

A Kromminga

6

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

V Quarmby

7

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

S Richards

8

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

C K Schneider

9

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

M Subramanyam

10

1 reference

Europe PubMed Central

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29 July 2017

S Swanson

11

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

D Verthelyi

12

1 reference

Europe PubMed Central

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29 July 2017

S Yim

13

1 reference

Europe PubMed Central

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29 July 2017

American Association of Pharmaceutical Scientists

14

1 reference

Europe PubMed Central

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29 July 2017

language of work or name

0 references

publication date

24 April 2014

1 reference

Europe PubMed Central

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29 July 2017

The AAPS Journal

1 reference

Europe PubMed Central

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29 July 2017

16

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

4

1 reference

Europe PubMed Central

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29 July 2017

658-673

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

Development of a method that eliminates false-positive results due to nerve growth factor interference in the assessment of fulranumab immunogenicity

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Theoretical considerations and practical approaches to address the effect of anti-drug antibody (ADA) on quantification of biotherapeutics in circulation

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatic diseases

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Assessing response and loss of response to biological therapies in IBD.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

How to systematically evaluate immunogenicity of therapeutic proteins - regulatory considerations

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Dealing with immunogenicity of biologicals: assessment and clinical relevance

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

The incidence and significance of anti-natalizumab antibodies: results from AFFIRM and SENTINEL.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Comparing ELISA and surface plasmon resonance for assessing clinical immunogenicity of panitumumab

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Infusion reactions and their management

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Immunogenicity of xenopeptide hormone therapies

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Antibody-mediated pure red cell aplasia (PRCA): epidemiology, immunogenicity and risks

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

A comprehensive review and evaluation of the side effects of the tumor necrosis factor alpha blockers etanercept, infliximab and adalimumab

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Immunogenicity of recombinant human proteins: causes and consequences

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Immunogenicity of therapeutic proteins: clinical implications and future prospects

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Immune responses to therapeutic proteins in humans--clinical significance, assessment and prediction

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Bioequivalence and the immunogenicity of biopharmaceuticals

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Danger signals: SOS to the immune system

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Will immunogenicity limit the use, efficacy, and future development of therapeutic monoclonal antibodies?

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

The use of relative operating characteristic (ROC) curves in test performance evaluation

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

Immunogenicity signals 1,2,3 ... and 0.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

4 July 2018

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

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

30 October 2018

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

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

30 October 2018

Taking immunogenicity assessment of therapeutic proteins to the next level.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

30 October 2018

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

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

30 October 2018

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4070270

30 October 2018

Prevalence, characteristics and diabetes risk associated with transient maternally acquired islet antibodies and persistent islet antibodies in offspring of parents with type 1 diabetes

1 reference

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30 October 2018

Predictive value of persistent versus transient antiphospholipid antibody subtypes for the risk of thrombotic events in pediatric patients with systemic lupus erythematosus

1 reference

https://pubmed.ncbi.nlm.nih.gov/24764037

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Cut-off levels and diagnostic accuracy of infliximab trough levels and anti-infliximab antibodies in Crohn's disease

1 reference

https://pubmed.ncbi.nlm.nih.gov/24764037

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Venous and arterial thromboembolic events in adalimumab-treated patients with antiadalimumab antibodies: a case series and cohort study

1 reference

https://pubmed.ncbi.nlm.nih.gov/24764037

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Serum sickness secondary to treatment with the murine-human chimeric antibody IDEC-C2B8 (rituximab)

1 reference

https://pubmed.ncbi.nlm.nih.gov/24764037

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based on heuristic

inferred from PubMed ID database lookup

Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products

1 reference

https://pubmed.ncbi.nlm.nih.gov/24764037

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Identifiers

10.1208/S12248-014-9599-2

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

Dimensions Publication ID

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PMC publication ID

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

PubMed publication ID

1 reference

Europe PubMed Central

PubMed publication ID

29 July 2017

ResearchGate publication ID

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