Publications by authors named "Martin Ullmann"

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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 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).
Johanna Mora, Rachel Palmer, Leslie Wagner, Bonnie Wu, Michael Partridge, Martin Ullmann

Bioanalysis· April 2024

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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.
Anna Zubrzycka-Sienkiewicz, Kamilla Klama, Martin Ullmann, Corinne Petit-Frere, Peter Baker

RMD Open· February 2024

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Pharmacokinetics of a proposed tocilizumab biosimilar (MSB11456) versus US-licensed tocilizumab: results of a randomized, double-blind, single-intravenous dose study in healthy adults.
Monika Tomaszewska-Kiecana, Martin Ullmann, Corinne Petit-Frere, Joëlle Monnet, Christos Dagres

Expert Rev Clin Immunol· April 2023

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Pharmacokinetics and tolerability of prefilled syringe and auto-injector presentations of MSB11456: results of a randomized, single-dose study in healthy adults.
Monika Tomaszewska-Kiecana, Anna Dryja, Martin Ullmann, Corinne Petit-Frere, Andras Illes

Expert Rev Clin Immunol· April 2023

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Pharmacokinetics and pharmacodynamics of a proposed tocilizumab biosimilar MSB11456 versus both the US-licensed and EU-approved products: a randomized, double-blind trial.
Christian Schwabe, Andras Illes, Martin Ullmann, Vishal Ghori, Emmanuelle Vincent

Expert Rev Clin Immunol· May 2022

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When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform.
Gregor P Lotz, Karin Benstein, Karien Bloem, Harm Buddiger, Claudio Calonder, Martin Ullmann

AAPS J· May 2022

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Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta in Healthy Subjects: A Randomized, Double-blind Trial.
Jason Lickliter, Radmila Kanceva, Emmanuelle Vincent, Armin Schueler, Eleanor Harrison-Moench, Martin Ullmann

Clin Ther· August 2020

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Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta in healthy subjects: A randomized, double-blind trial.
Chris Wynne, Christian Schwabe, Emmanuelle Vincent, Armin Schueler, Janka Ryding, Martin Ullmann

Pharmacol Res Perspect· April 2020

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Safety of adalimumab biosimilar MSB11022 (acetate-buffered formulation) in patients with moderately-to-severely active rheumatoid arthritis.
Christopher J Edwards, Joëlle Monnet, Martin Ullmann, Pantelis Vlachos, Veranika Chyrok

Clin Rheumatol· December 2019

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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).
Lauren Stevenson, Susan Richards, Renuka Pillutla, Albert Torri, John Kamerud, Martin Ullmann

Bioanalysis· December 2018

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Demonstrating biosimilar and originator antidrug antibody binding comparability in antidrug antibody assays: a practical approach.
Janka Ryding, Michael Stahl, Martin Ullmann

Bioanalysis· September 2017

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2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).
Susan Richards, Lakshmi Amaravadi, Renuka Pillutla, Herbert Birnboeck, Albert Torri, Martin Ullmann

Bioanalysis· December 2016

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Comparison of the pharmacokinetics, safety, and immunogenicity of MSB11022, a biosimilar of adalimumab, with Humira(®) in healthy subjects.
Elizabeth Hyland, Tim Mant, Pantelis Vlachos, Neil Attkins, Martin Ullmann

Br J Clin Pharmacol· October 2016

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Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.
JoMarie Smolec, Binodh DeSilva, Wendell Smith, Russell Weiner, Marian Kelly, Martin Ullmann

Pharm Res· September 2005

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