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1.
Safety, Tolerability and Pharmacokinetics of Half-Life Extended Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Monoclonal Antibodies AZD7442 (Tixagevimab-Cilgavimab) in Healthy Adults.
J Infect Dis;
227(10): 1153-1163, 2023 05 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-36683419
2.
Multiplex Hybrid Antigen-Capture LC-MRM Quantification in Sera and Nasal Lining Fluid of AZD7442, a SARS-CoV-2-Targeting Antibody Combination.
Anal Chem;
94(43): 14835-14845, 2022 11 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-36269894
3.
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).
Bioanalysis;
16(7): 77-119, 2024 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-38389403
4.
Safety of Re-dosing Nirsevimab Prior to RSV Season 2 in Children With Heart or Lung Disease.
J Pediatric Infect Dis Soc;
12(8): 477-480, 2023 Aug 31.
Artículo
en Inglés
| MEDLINE | ID: mdl-37466917
5.
Multiplex Bioanalytical Methods for Comprehensive Characterization and Quantification of the Unique Complementarity-Determining-Region Deamidation of MEDI7247, an Anti-ASCT2 Pyrrolobenzodiazepine Antibody-Drug Conjugate.
Antibodies (Basel);
12(4)2023 Oct 17.
Artículo
en Inglés
| MEDLINE | ID: mdl-37873863
6.
Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium.
AAPS J;
24(4): 81, 2022 07 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-35821280
7.
Confirmatory cut point has limited ability to make accurate classifications in immunogenicity assays.
Bioanalysis;
12(4): 245-256, 2020 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-32090586
8.
A new method for identification of outliers in immunogenicity assay cut point data.
J Immunol Methods;
484-485: 112817, 2020.
Artículo
en Inglés
| MEDLINE | ID: mdl-32615125
9.
Excessive outlier removal may result in cut points that are not suitable for immunogenicity assessments.
J Immunol Methods;
463: 105-111, 2018 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-30312600
10.
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
11.
Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays.
J Immunol Res;
2016: 1485615, 2016.
Artículo
en Inglés
| MEDLINE | ID: mdl-27478855
12.
Statistical methods and tool for cut point analysis in immunogenicity assays.
J Immunol Methods;
389(1-2): 79-87, 2013 Mar 29.
Artículo
en Inglés
| MEDLINE | ID: mdl-23305975
13.
Correlation of screening and confirmatory results in tiered immunogenicity testing by solution-phase bridging assays.
J Pharm Biomed Anal;
74: 235-45, 2013 Feb 23.
Artículo
en Inglés
| MEDLINE | ID: mdl-23245256
14.
Phosphorothiolate analogues of phosphatidylinositols as assay substrates for phospholipase C.
Chembiochem;
8(12): 1430-9, 2007 Aug 13.
Artículo
en Inglés
| MEDLINE | ID: mdl-17659518
15.
Comprehensive and uniform synthesis of all naturally occurring phosphorylated phosphatidylinositols.
J Org Chem;
68(3): 960-8, 2003 Feb 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-12558421
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