Detalles de la búsqueda
1.
Early antibody responses associated with survival in COVID19 patients.
PLoS Pathog
; 17(7): e1009766, 2021 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-34280244
2.
Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination.
Vaccine
; 41(28): 4183-4189, 2023 06 23.
Artículo
en Inglés
| MEDLINE | ID: mdl-37244808
3.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Bioanalysis
; 15(14): 773-814, 2023 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-37526071
4.
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Bioanalysis
; 14(11): 737-793, 2022 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578991
5.
Anti-drug Antibody Sample Testing and Reporting Harmonization.
AAPS J
; 24(6): 113, 2022 10 28.
Artículo
en Inglés
| MEDLINE | ID: mdl-36307592
6.
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Bioanalysis
; 13(6): 415-463, 2021 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-33533276
7.
Anti-drug Antibody Validation Testing and Reporting Harmonization.
AAPS J
; 24(1): 4, 2021 12 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-34853961
8.
A Model-Based Approach to Quantify the Time-Course of Anti-Drug Antibodies for Therapeutic Proteins.
Clin Pharmacol Ther
; 105(4): 970-978, 2019 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-30372517
9.
Report on the AAPS Immunogenicity Guidance Forum.
AAPS J
; 21(4): 55, 2019 04 16.
Artículo
en Inglés
| MEDLINE | ID: mdl-30993501
10.
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).
Bioanalysis
; 11(23): 2099-2132, 2019 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-31833782
11.
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).
Bioanalysis
; 11(24): 2207-2244, 2019 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-31820675
12.
Anti-PEG IgE in anaphylaxis associated with polyethylene glycol.
J Allergy Clin Immunol Pract
; 9(4): 1731-1733.e3, 2021 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-33217616
13.
FDA Approval: Blinatumomab.
Clin Cancer Res
; 21(18): 4035-9, 2015 Sep 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-26374073
14.
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).
Bioanalysis
; 7(24): 3107-24, 2015 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-26635247
15.
Mechanisms Underlying the Immunogenicity of Therapeutic Proteins: Risk Assessment and Management Strategies.
J Interferon Cytokine Res
; 34(12): 923-930, 2014 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-25493959
16.
New FDA draft guidance on immunogenicity.
AAPS J
; 16(3): 499-503, 2014 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-24682766
17.
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).
Bioanalysis
; 6(24): 3355-68, 2014.
Artículo
en Inglés
| MEDLINE | ID: mdl-25534792
18.
Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics.
J Pharm Biomed Anal
; 55(5): 878-88, 2011 Jul 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-21531522
19.
Neutralizing antibodies to therapeutic enzymes: considerations for testing, prevention and treatment.
Nat Biotechnol
; 26(8): 901-8, 2008 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-18688246
20.
Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.
J Pharm Sci
; 98(4): 1201-5, 2009 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-18704929
Resultados
1 -
20
de 20
1
Próxima >
>>