Detalles de la búsqueda
1.
The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria.
Blood
; 135(12): 912-920, 2020 03 19.
Artículo
en Inglés
| MEDLINE | ID: mdl-31978221
2.
Generation, Characterization, and Quantitative Bioanalysis of Drug/Anti-drug Antibody Immune Complexes to Facilitate Dedicated In Vivo Studies.
Pharm Res
; 36(9): 129, 2019 Jun 28.
Artículo
en Inglés
| MEDLINE | ID: mdl-31254106
3.
In Vivo Biotransformation of the Fusion Protein Tetranectin-Apolipoprotein A1 Analyzed by Ligand-Binding Mass Spectrometry Combined with Quantitation by ELISA.
Anal Chem
; 88(23): 11670-11677, 2016 12 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-27934109
4.
Biodistribution of Drug/ADA Complexes: The Impact of Immune Complex Formation on Antibody Distribution.
AAPS J
; 26(2): 33, 2024 03 13.
Artículo
en Inglés
| MEDLINE | ID: mdl-38478197
5.
Recommendations and feedback from the European Bioanalysis Forum Workshop: 1 year into ICH M10 - keeping our finger on the pulse.
Bioanalysis
; 16(5): 259-270, 2024 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-38315622
6.
Direct bioanalysis or indirect calculation of target engagement and free drug exposure: do we apply double standards?
Bioanalysis
; 15(1): 5-16, 2023 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-36762451
7.
High ionic strength dissociation assay reduces dimeric target interference in immunogenicity testing.
Bioanalysis
; 15(14): 823-832, 2023 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-37326333
8.
Immunocapture LC-MS(/MS) assays for biotherapeutic and biomarker proteins: the European Bioanalysis Forum continuing discussions on scientific and regulatory challenges.
Bioanalysis
; 15(9): 477-480, 2023 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-37318068
9.
Mitigating Drug-Target-Drug Complexes in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Switch C5 Inhibitors.
Clin Pharmacol Ther
; 113(4): 904-915, 2023 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-36660902
10.
Novel isoelectric target depletion (ITaD) protocol reduces the need for specific reagents for immunogenicity testing.
Bioanalysis
; 14(10): 725-735, 2022 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-35642540
11.
Validation of a method to analyze size distribution of crovalimab-complement C5-eculizumab complexes in human serum.
Bioanalysis
; 14(13): 935-947, 2022 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-35904159
12.
Comparison of assay formats used for the detection of pre-existing anti-drug antibodies against monoclonal antibodies.
Bioanalysis
; 14(13): 923-933, 2022 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-36066084
13.
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
14.
An Alternative Data Transformation Approach for ADA Cut Point Determination: Why Not Use a Weibull Transformation?
AAPS J
; 23(5): 97, 2021 08 13.
Artículo
en Inglés
| MEDLINE | ID: mdl-34389881
15.
The impact of immunogenicity on therapeutic antibody pharmacokinetics: A preclinical evaluation of the effect of immune complex formation and antibody effector function on clearance.
MAbs
; 13(1): 1995929, 2021.
Artículo
en Inglés
| MEDLINE | ID: mdl-34763611
16.
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 13(5): 295-361, 2021 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-33511867
17.
Toward comparability of anti-drug antibody assays: is the amount of anti-drug antibody-reagent complexes at cut-point (CP-ARC) the missing piece?
Bioanalysis
; 12(14): 1021-1031, 2020 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-32633539
18.
High ionic strength dissociation assay (HISDA) for high drug tolerant immunogenicity testing.
Bioanalysis
; 12(12): 857-866, 2020 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-32603603
19.
Protease-activation using anti-idiotypic masks enables tumor specificity of a folate receptor 1-T cell bispecific antibody.
Nat Commun
; 11(1): 3196, 2020 06 24.
Artículo
en Inglés
| MEDLINE | ID: mdl-32581215
20.
Evaluation of the potential use of hybrid LC-MS/MS for active drug quantification applying the 'free analyte QC concept'.
Bioanalysis
; 9(21): 1705-1717, 2017 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-28952783