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PubPharm (30)
1
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
enthalten in:
Bioanalysis
| 2024
von
Mora, J.
|
Palmer, R.
|
Wagner, L.
| +55
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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
enthalten in:
RMD open
| 2024
von
Zubrzycka-Sienkiewicz, A.
|
Klama, K.
|
Ullmann, M.
| +4
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3
Pharmacokinetics of a proposed tocilizumab biosimilar (MSB11456) versus US-licensed tocilizumab : results of a randomized, double-blind, single-intravenous dose study in healthy adults
enthalten in:
Expert review of clinical immunology
| 2023
von
Tomaszewska-Kiecana, M.
|
Ullmann, M.
|
Petit-Frere, C.
| +3
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4
Pharmacokinetics and tolerability of prefilled syringe and auto-injector presentations of MSB11456 : results of a randomized, single-dose study in healthy adults
enthalten in:
Expert review of clinical immunology
| 2023
von
Tomaszewska-Kiecana, M.
|
Dryja, A.
|
Ullmann, M.
| +4
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5
Pharmacokinetics and pharmacodynamics of a proposed tocilizumab biosimilar MSB11456 versus both the US-licensed and EU-approved products : a randomized, double-blind trial
enthalten in:
Expert review of clinical immunology
| 2022
von
Schwabe, C.
|
Illes, A.
|
Ullmann, M.
| +6
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6
When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials : an Opinion from the European Immunogenicity Platform
enthalten in:
The AAPS journal
| 2022
von
Lotz, G.
|
Benstein, K.
|
Bloem, K.
| +19
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7
When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform
enthalten in:
The AAPS journal
| 2022
von
Lotz, G.
|
Benstein, K.
|
Bloem, K.
| +19
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8
When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform
enthalten in:
AAPS PharmSci
| 2022
von
Lotz, G.
|
Benstein, K.
|
Bloem, K.
| +19
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9
Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta in Healthy Subjects : A Randomized, Double-blind Trial
enthalten in:
Clinical therapeutics
| 2020
von
Lickliter, J.
|
Kanceva, R.
|
Vincent, E.
| +7
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10
Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta® in healthy subjects : A randomized, double-blind trial
enthalten in:
Pharmacology research & perspectives
| 2020
von
Wynne, C.
|
Schwabe, C.
|
Vincent, E.
| +6
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Biosimilar Pharmaceuticals
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Randomized Controlled Trial
6
Research Support, Non-U.S. Gov't
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Adalimumab
5
immunogenicity
5
pharmacokinetics
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I031V2H011
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Rheumatoid arthritis
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tocilizumab
3
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MSB11456
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biosimilarity
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