Detalles de la búsqueda
1.
Comparison of the pharmacokinetics, safety, and immunogenicity of MSB11022, a biosimilar of adalimumab, with Humira(®) in healthy subjects.
Br J Clin Pharmacol
; 82(4): 983-93, 2016 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-27285856
2.
Comparison of the efficacy and safety of a proposed biosimilar MSB11456 with tocilizumab reference product in subjects with moderate-to-severe rheumatoid arthritis: results of a randomised double-blind study.
RMD Open
; 10(1)2024 Feb 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-38316489
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.
Pharmacokinetics and tolerability of prefilled syringe and auto-injector presentations of MSB11456: results of a randomized, single-dose study in healthy adults.
Expert Rev Clin Immunol
; 19(4): 447-455, 2023 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-36789991
5.
Pharmacokinetics of a proposed tocilizumab biosimilar (MSB11456) versus US-licensed tocilizumab: results of a randomized, double-blind, single-intravenous dose study in healthy adults.
Expert Rev Clin Immunol
; 19(4): 439-446, 2023 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-36715299
6.
Pharmacokinetics and pharmacodynamics of a proposed tocilizumab biosimilar MSB11456 versus both the US-licensed and EU-approved products: a randomized, double-blind trial.
Expert Rev Clin Immunol
; 18(5): 533-543, 2022 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-35354411
7.
When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform.
AAPS J
; 24(3): 68, 2022 05 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-35554731
8.
Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta® in healthy subjects: A randomized, double-blind trial.
Pharmacol Res Perspect
; 8(2): e00578, 2020 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-32333641
9.
Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta in Healthy Subjects: A Randomized, Double-blind Trial.
Clin Ther
; 42(8): 1508-1518.e1, 2020 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-32660769
10.
Safety of adalimumab biosimilar MSB11022 (acetate-buffered formulation) in patients with moderately-to-severely active rheumatoid arthritis.
Clin Rheumatol
; 38(12): 3381-3390, 2019 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-31396834
11.
Demonstrating biosimilar and originator antidrug antibody binding comparability in antidrug antibody assays: a practical approach.
Bioanalysis
; 9(18): 1395-1406, 2017 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-28920451
12.
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).
Bioanalysis
; 8(23): 2475-2496, 2016 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-27855512
13.
Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.
Pharm Res
; 22(9): 1425-31, 2005 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-16132353
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