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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.
Schwabe C, Illes A, Ullmann M, Ghori V, Vincent E, Petit-Frere C, Monnet J, Racault AS, Wynne C. Schwabe C, et al. Among authors: wynne c. Expert Rev Clin Immunol. 2022 May;18(5):533-543. doi: 10.1080/1744666X.2022.2060204. Epub 2022 Apr 10. Expert Rev Clin Immunol. 2022. PMID: 35354411 Clinical Trial.
A randomized, adaptive design, double-blind, 3-arm, parallel study assessing the pharmacokinetics and safety of AVT02, a high-concentration (100 mg/mL) Adalimumab biosimilar, in healthy adult subjects (ALVOPAD FIRST).
Wynne C, Schwabe C, Lemech C, Stroissnig H, Dias R, Sobierska J, Guenzi E, Otto H, Sattar A, Kay R, Haliduola HN, Berti F. Wynne C, et al. Expert Opin Investig Drugs. 2022 Sep;31(9):965-976. doi: 10.1080/13543784.2022.2035359. Epub 2022 Feb 10. Expert Opin Investig Drugs. 2022. PMID: 35107050 Clinical Trial.
Reply to: letter to the editor "subcutaneous herceptin therapy".
Wynne C, Harvey V, Schwabe C, Waaka D, McIntyre C, Bittner B. Wynne C, et al. J Clin Pharmacol. 2013 Dec;53(12):1343-4. doi: 10.1002/jcph.172. Epub 2013 Sep 21. J Clin Pharmacol. 2013. PMID: 23996383 No abstract available.
A multicenter, randomized, open-label, 2-arm parallel study to compare the pharmacokinetics, safety and tolerability of AVT02 administered subcutaneously via prefilled syringe or autoinjector in healthy adults.
Wynne C, Schwabe C, Stroissnig H, Dias R, Sobierska J, Guenzi E, Otto H, Sattar A, Haliduola HN, Edwald E, Berti F. Wynne C, et al. Expert Opin Biol Ther. 2023 Jul-Dec;23(8):773-780. doi: 10.1080/14712598.2022.2131391. Epub 2022 Oct 5. Expert Opin Biol Ther. 2023. PMID: 36197309
Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects.
Wynne C, Altendorfer M, Sonderegger I, Gheyle L, Ellis-Pegler R, Buschke S, Lang B, Assudani D, Athalye S, Czeloth N. Wynne C, et al. Expert Opin Investig Drugs. 2016 Dec;25(12):1361-1370. doi: 10.1080/13543784.2016.1255724. Expert Opin Investig Drugs. 2016. PMID: 27813422 Clinical Trial.
238 results