Detalles de la búsqueda
1.
Protein Biomarker Quantification by Immunoaffinity Liquid Chromatography-Tandem Mass Spectrometry: Current State and Future Vision.
Clin Chem
; 66(2): 282-301, 2020 02 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-32040572
2.
Evidence of activation of the Nrf2 pathway in multiple sclerosis patients treated with delayed-release dimethyl fumarate in the Phase 3 DEFINE and CONFIRM studies.
Mult Scler
; 23(14): 1875-1883, 2017 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-28156185
3.
In vivo maintenance of human regulatory T cells during CD25 blockade.
J Immunol
; 194(1): 84-92, 2015 Jan 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-25416807
4.
Population PK-PD analyses of CD25 occupancy, CD56bright NK cell expansion, and regulatory T cell reduction by daclizumab HYP in subjects with multiple sclerosis.
Br J Clin Pharmacol
; 82(5): 1333-1342, 2016 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-27333593
5.
Anti-drug Antibody Validation Testing and Reporting Harmonization.
AAPS J
; 24(1): 4, 2021 12 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-34853961
6.
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
7.
Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.
Regul Toxicol Pharmacol
; 54(2): 164-82, 2009 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-19345250
8.
An LC-MS/MS approach to assess total and free protein target in the serum of cynomolgus monkey.
Bioanalysis
; 11(5): 393-406, 2019 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-30874444
9.
A sensitive antibody-free 2D-LC-MS/MS assay for the quantitation of myostatin in the serum of different species.
Bioanalysis
; 11(10): 957-970, 2019 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-31218899
10.
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
11.
Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products.
J Pharm Biomed Anal
; 48(5): 1267-81, 2008 Dec 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-18993008
12.
A novel LC-MS/MS assay to quantify dermatan sulfate in cerebrospinal fluid as a biomarker for mucopolysaccharidosis II.
Bioanalysis
; 10(11): 825-838, 2018 Jun 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-29863901
13.
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).
Bioanalysis
; 10(24): 1973-2001, 2018 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-30488726
14.
Recommendations for clinical biomarker specimen preservation and stability assessments.
Bioanalysis
; 9(8): 643-653, 2017 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-28508714
15.
Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?
AAPS J
; 24(3): 65, 2022 05 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-35511303
16.
Recommendations for Selection and Characterization of Protein Biomarker Assay Calibrator Material.
AAPS J
; 19(6): 1550-1563, 2017 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-28971363
17.
Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development.
AAPS J
; 19(6): 1576-1586, 2017 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-29110222
18.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-29205064
19.
Critical reagents: evolution of WRIB recommendations on critical reagents.
Bioanalysis
; 13(10): 741-743, 2021 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-33890504
20.
Current and effective strategies for critical reagent characterization, storage, stability, retesting and life cycle management for ligand-binding assays and flow cytometry.
Bioanalysis
; 13(10): 737-740, 2021 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-34037426