Detalhe da pesquisa
1.
The synthesis of [14 C]4-acetylphenylalanine, effect on cell viability, and assessment of protein incorporation in male rat hepatocytes.
J Labelled Comp Radiopharm
; 60(8): 352-356, 2017 06 30.
Artigo
em Inglês
| MEDLINE | ID: mdl-28273378
2.
Innovative use of LC-MS/MS for simultaneous quantitation of neutralizing antibody, residual drug, and human immunoglobulin G in immunogenicity assay development.
Anal Chem
; 86(5): 2673-80, 2014 Mar 04.
Artigo
em Inglês
| MEDLINE | ID: mdl-24506335
3.
An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR-T and TCR-T Cellular Therapies Development.
Clin Pharmacol Ther
; 115(2): 188-200, 2024 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-37983584
4.
Neutralizing Antibody Validation Testing and Reporting Harmonization.
AAPS J
; 25(4): 69, 2023 07 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-37421491
5.
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.
Artigo
em Inglês
| MEDLINE | ID: mdl-35578991
6.
The Clinical Pharmacology of Elotuzumab.
Clin Pharmacokinet
; 57(3): 297-313, 2018 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-28779463
7.
Bead-extraction and heat-dissociation (BEHD): A novel way to overcome drug and matrix interference in immunogenicity testing.
J Immunol Methods
; 462: 34-41, 2018 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-30099014
8.
Development and validation of a functional cell-based neutralizing antibody assay for ipilimumab.
Bioanalysis
; 10(16): 1273-1287, 2018 Aug 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-29947549
9.
Concerted application of LC-MS and ligand binding assays to better understand exposure of a large molecule drug.
Bioanalysis
; 10(16): 1261-1272, 2018 Aug 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-29923414
10.
2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).
Bioanalysis
; 10(22): 1781-1801, 2018 Nov 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-30488725
11.
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).
Bioanalysis
; 10(23): 1897-1917, 2018 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-30488729
12.
Challenges and opportunities in bioanalytical support for gene therapy medicinal product development.
Bioanalysis
; 9(18): 1423-1430, 2017 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-28920452
13.
An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab.
AAPS J
; 19(2): 557-567, 2017 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-28070715
14.
A systematic study of the effect of low pH acid treatment on anti-drug antibodies specific for a domain antibody therapeutic: Impact on drug tolerance, assay sensitivity and post-validation method assessment of ADA in clinical serum samples.
J Immunol Methods
; 448: 91-104, 2017 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-28625864
15.
Development and characterization of a pre-treatment procedure to eliminate human monoclonal antibody therapeutic drug and matrix interference in cell-based functional neutralizing antibody assays.
J Immunol Methods
; 416: 94-104, 2015 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-25445325
16.
Development of a Generic Anti-PEG Antibody Assay Using BioScale's Acoustic Membrane MicroParticle Technology.
AAPS J
; 17(6): 1511-6, 2015 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-26139446
17.
Development and characterization of antibody reagents to assess anti-PEG IgG antibodies in clinical samples.
Bioanalysis
; 7(15): 1869-83, 2015.
Artigo
em Inglês
| MEDLINE | ID: mdl-26295988
18.
Anti-PEG antibody bioanalysis: a clinical case study with PEG-IFN-λ-1a and PEG-IFN-α2a in naive patients.
Bioanalysis
; 7(9): 1093-106, 2015.
Artigo
em Inglês
| MEDLINE | ID: mdl-26039807
19.
Liquid chromatography coupled with tandem mass spectrometry for the bioanalysis of proteins in drug development: practical considerations in assay development and validation.
J Chromatogr A
; 1284: 155-62, 2013 Apr 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-23466204
20.
The future of immunocapture-capillary electrophoresis-high resolution mass spectrometry.
Bioanalysis
; 9(21): 1627-1631, 2017 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-29095042