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1.
Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions.
Cephalalgia
; 42(8): 749-760, 2022 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-35272533
2.
Assessment of romiplostim immunogenicity in adult patients in clinical trials and in a global postmarketing registry.
Br J Haematol
; 190(6): 923-932, 2020 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-32311075
3.
A randomized, double-blind, single-dose, three-arm, parallel group study to determine pharmacokinetic similarity of ABP 959 and eculizumab (Soliris® ) in healthy male subjects.
Eur J Haematol
; 105(1): 66-74, 2020 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-32196749
4.
Risk of pure red cell aplasia in patients with hepatitis C receiving antiviral therapy and an erythropoiesis-stimulating agent.
Clin Gastroenterol Hepatol
; 12(2): 341-5, 2014 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-24120841
5.
Dose-related differences in the pharmacodynamic and toxicologic response to a novel hyperglycosylated analog of recombinant human erythropoietin in Sprague-Dawley rats with similarly high hematocrit.
Toxicol Pathol
; 42(3): 524-39, 2014.
Artículo
en Inglés
| MEDLINE | ID: mdl-23674391
6.
Cytokines associated with increased erythropoiesis in Sprague-Dawley rats administered a novel hyperglycosylated analog of recombinant human erythropoietin.
Toxicol Pathol
; 42(3): 540-54, 2014.
Artículo
en Inglés
| MEDLINE | ID: mdl-23674392
7.
The T-cell-dependent antibody response assay in nonclinical studies of pharmaceuticals and chemicals: study design, data analysis, interpretation.
Regul Toxicol Pharmacol
; 69(1): 7-21, 2014 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-24566336
8.
Translatability of findings from cynomolgus monkey to human suggests a mechanistic role for IL-21 in promoting immunogenicity to an anti-PD-1/IL-21 mutein fusion protein.
Front Immunol
; 15: 1345473, 2024.
Artículo
en Inglés
| MEDLINE | ID: mdl-38343535
9.
Pharmacokinetic Similarity of ABP 654, an Ustekinumab Biosimilar Candidate: Results from a Randomized, Double-blind Study in Healthy Subjects.
Clin Pharmacol Drug Dev
; 12(9): 863-873, 2023 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-37415567
10.
Characterization and root cause analysis of immunogenicity to pasotuxizumab (AMG 212), a prostate-specific membrane antigen-targeting bispecific T-cell engager therapy.
Front Immunol
; 14: 1261070, 2023.
Artículo
en Inglés
| MEDLINE | ID: mdl-37942314
11.
A detailed examination of the antibody prevalence and characteristics of anti-ESA antibodies.
Nephrol Dial Transplant
; 27(10): 3892-9, 2012 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-23114907
12.
Detection of anti-ESA antibodies in human samples from PRCA and non-PRCA patients: an immunoassay platform comparison.
Nephrol Dial Transplant
; 27(2): 688-93, 2012 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-21602184
13.
Immunogenicity assessment of bispecific antibody-based immunotherapy in oncology.
J Immunother Cancer
; 10(4)2022 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-35444060
14.
Assessment of romiplostim immunogenicity in pediatric patients in clinical trials and in a global postmarketing registry.
Blood Adv
; 5(23): 4969-4979, 2021 12 14.
Artículo
en Inglés
| MEDLINE | ID: mdl-34638135
15.
Immune Complex Formation Is Associated With Loss of Tolerance and an Antibody Response to Both Drug and Target.
Front Immunol
; 12: 782788, 2021.
Artículo
en Inglés
| MEDLINE | ID: mdl-34970265
16.
Clinical Immunogenicity Risk Assessment for a Fusion Protein.
AAPS J
; 22(3): 64, 2020 04 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-32246297
17.
The development and validation of a sensitive, dual-flow cell, SPR-based biosensor immunoassay for the detection, semi-quantitation, and characterization of antibodies to darbepoetin alfa and epoetin alfa in human serum.
J Pharm Biomed Anal
; 49(2): 415-26, 2009 Feb 20.
Artículo
en Inglés
| MEDLINE | ID: mdl-19135328
18.
A Proposal to Redefine Clinical Immunogenicity Assessment.
AAPS J
; 19(3): 599-602, 2017 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-28247192
19.
Assay signal as an alternative to titer for assessment of magnitude of an antidrug antibody response.
Bioanalysis
; 9(23): 1849-1858, 2017 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-29020795
20.
Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study.
J Immunol Methods
; 435: 32-42, 2016 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-27173074