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1.
High-Throughput Therapeutic Antibody Interference-Free High-Resolution Mass Spectrometry Assay for Monitoring M-Proteins in Multiple Myeloma.
Anal Chem
; 93(2): 834-842, 2021 01 19.
Artículo
en Inglés
| MEDLINE | ID: mdl-33300779
2.
Antipeptide Immunocapture with In-Sample Calibration Curve Strategy for Sensitive and Robust LC-MS/MS Bioanalysis of Clinical Protein Biomarkers in Formalin-Fixed Paraffin-Embedded Tumor Tissues.
Anal Chem
; 92(21): 14713-14722, 2020 11 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-33047598
3.
In-Sample Calibration Curve Using Multiple Isotopologue Reaction Monitoring of a Stable Isotopically Labeled Analyte for Instant LC-MS/MS Bioanalysis and Quantitative Proteomics.
Anal Chem
; 91(3): 2536-2543, 2019 02 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-30615432
4.
Eliminating Preparation of Multisample External Calibration Curves and Dilution of Study Samples Using the Multiple Isotopologue Reaction Monitoring (MIRM) Technique in Quantitative LC-MS/MS Bioanalysis.
Anal Chem
; 91(13): 8652-8659, 2019 07 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-31180205
5.
Determination of Real Time in Vivo Drug Receptor Occupancy for a Covalent Binding Drug as a Clinical Pharmacodynamic Biomarker by Immunocapture-LC-MS/MS.
Anal Chem
; 91(13): 8443-8452, 2019 07 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-31247719
6.
Slow Off-Rate Modified Aptamer (SOMAmer) as a Novel Reagent in Immunoassay Development for Accurate Soluble Glypican-3 Quantification in Clinical Samples.
Anal Chem
; 90(8): 5162-5170, 2018 04 17.
Artículo
en Inglés
| MEDLINE | ID: mdl-29605994
7.
Prevalence of Pre-Existing Neutralizing Antibodies Against Adeno-Associated Virus Serotypes 1, 2, 5, 6, 8, and 9 in Sera of Different Pig Strains.
Hum Gene Ther
; 33(7-8): 451-459, 2022 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-34913759
8.
Application of in-sample calibration curve methodology for regulated bioanalysis: Critical considerations in method development, validation and sample analysis.
J Pharm Biomed Anal
; 177: 112844, 2020 Jan 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-31491659
9.
Recommendations for singlet-based approach in ligand binding assays: an IQ Consortium perspective.
Bioanalysis
; 12(12): 823-834, 2020 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-32558588
10.
A Fit-for-Purpose Method for the Detection of Human Antibodies to Surface-Exposed Components of BMS-986263, a Lipid Nanoparticle-Based Drug Product Containing a siRNA Drug Substance.
AAPS J
; 21(5): 92, 2019 07 22.
Artículo
en Inglés
| MEDLINE | ID: mdl-31332587
11.
Perspectives on exploring hybrid LBA/LC-MS approach for clinical immunogenicity testing.
Bioanalysis
; 11(17): 1605-1617, 2019 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-31208198
12.
A practical workflow for capillary microsampling in nonclinical studies.
Bioanalysis
; 11(3): 175-184, 2019 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-30767556
13.
A convenient strategy to overcome interference in LC-MS/MS analysis: Application in a microdose absolute bioavailability study.
J Pharm Biomed Anal
; 165: 198-206, 2019 Feb 20.
Artículo
en Inglés
| MEDLINE | ID: mdl-30553110
14.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-31342199
15.
2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays (Part 1 - Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis).
Bioanalysis
; 11(22): 2029-2048, 2019 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-31808716
16.
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
17.
Development and validation of a functional cell-based neutralizing antibody assay for ipilimumab.
Bioanalysis
; 10(16): 1273-1287, 2018 Aug 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-29947549
18.
Development of a Chemiluminescent ELISA Method for the Detection of Total Anti-Adeno Associated Virus Serotype 9 (AAV9) Antibodies.
Hum Gene Ther Methods
; 29(6): 237-250, 2018 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-30351228
19.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-30099014
20.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-29923414