Detalhe da pesquisa
1.
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
2.
Fully validated LC-MS/MS assay for the simultaneous quantitation of coadministered therapeutic antibodies in cynomolgus monkey serum.
Anal Chem
; 85(20): 9859-67, 2013 Oct 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-24024648
3.
The Journey to AAPS 2020: a Reflection from Strategic Planning to PharmSci 360.
AAPS PharmSciTech
; 19(8): 3325-3327, 2018 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-30390237
4.
Suppression of angiogenesis and tumor growth by selective inhibition of angiopoietin-2.
Cancer Cell
; 6(5): 507-16, 2004 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-15542434
5.
Biomarker Assay Validation by Mass Spectrometry.
AAPS J
; 24(3): 66, 2022 05 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-35534647
6.
Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins.
J Pharm Biomed Anal
; 49(2): 311-8, 2009 Feb 20.
Artigo
em Inglês
| MEDLINE | ID: mdl-19150188
7.
Report on the AAPS Immunogenicity Guidance Forum.
AAPS J
; 21(4): 55, 2019 04 16.
Artigo
em Inglês
| MEDLINE | ID: mdl-30993501
8.
Evaluating a Multiscale Mechanistic Model of the Immune System to Predict Human Immunogenicity for a Biotherapeutic in Phase 1.
AAPS J
; 21(5): 94, 2019 07 24.
Artigo
em Inglês
| MEDLINE | ID: mdl-31342199
9.
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
10.
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
11.
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
12.
Surface plasmon resonance as a tool for ligand-binding assay reagent characterization in bioanalysis of biotherapeutics.
Bioanalysis
; 10(8): 559-576, 2018 Apr 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-29701071
13.
Characterization of labeled reagents in ligand-binding assays by a surface plasmon resonance biosensor.
Bioanalysis
; 9(2): 193-207, 2017 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-27960543
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.
A multiplexed immunocapture liquid chromatography tandem mass spectrometry assay for the simultaneous measurement of myostatin and GDF-11 in rat serum using an automated sample preparation platform.
Anal Chim Acta
; 979: 36-44, 2017 Aug 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-28599707
16.
Accelerating Regulated Bioanalysis for Biotherapeutics: Case Examples Using a Microfluidic Ligand Binding Assay Platform.
AAPS J
; 19(1): 82-91, 2017 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-27796911
17.
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
Bioanalysis
; 9(24): 1967-1996, 2017 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-29205064
18.
Validation of an integrated series of ligand-binding assays for the quantitative determination of antibody-drug conjugates in biological matrices.
Bioanalysis
; 8(6): 519-31, 2016 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-26915587
19.
Current Challenges and Potential Opportunities for the Pharmaceutical Sciences to Make Global Impact: An FIP Perspective.
J Pharm Sci
; 105(9): 2489-2497, 2016 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-26886325
20.
Antibody-drug conjugate bioanalysis using LB-LC-MS/MS hybrid assays: strategies, methodology and correlation to ligand-binding assays.
Bioanalysis
; 8(13): 1383-401, 2016 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-27277879