Joint analysis of PK and immunogenicity outcomes using factorization model − a powerful approach for PK similarity study
Haliduola, Halimu N., Berti, Fausto, Stroissnig, Heimo, Guenzi, Eric, Otto, Hendrik, Sattar, Abid, Mansmann, Ulrich
Published in BMC medical research methodology (08.10.2022)
Published in BMC medical research methodology (08.10.2022)
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42913 Assessment of Therapeutic Equivalence Between Candidate Biosimilar AVT04 and Reference Ustekinumab
Stroissnig, Heimo, Feldman, Steven, Berti, Fausto, Duijzings, Paul, Ruffieux, Ruth, Sobierska, Joanna, Otto, Hendrik, Haliduola, Halimu
Published in Journal of the American Academy of Dermatology (01.09.2023)
Published in Journal of the American Academy of Dermatology (01.09.2023)
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Journal Article
42601 Assessment of Bioequivalence Between Candidate Biosimilar AVT04 and Reference Ustekinumab
Berti, Fausto, Wynne, Chris, Stroissnig, Heimo, Smith, Matthew, Duijzings, Paul, Ruffieux, Ruth, Sobierska, Joanna, Otto, Hendrik, Sattar, Abid, Haliduola, Halimu
Published in Journal of the American Academy of Dermatology (01.09.2023)
Published in Journal of the American Academy of Dermatology (01.09.2023)
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A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in healthy adults
Wynne, Christopher, Hamilton, Paul, McLendon, Kristi, Stroissnig, Heimo, Smith, Matthew, Duijzings, Paul, Ruffieux, Ruth, Otto, Hendrik, Sattar, Abid, Haliduola, Halimu N., Leutz, Steffen, Berti, Fausto
Published in Expert opinion on investigational drugs (04.05.2023)
Published in Expert opinion on investigational drugs (04.05.2023)
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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, Christopher, Schwabe, Christian, Lemech, Charlotte, Stroissnig, Heimo, Dias, Roshan, Sobierska, Joanna, Guenzi, Eric, Otto, Hendrik, Sattar, Abid, Kay, Richard, Haliduola, Halimu N., Berti, Fausto
Published in Expert opinion on investigational drugs (02.09.2022)
Published in Expert opinion on investigational drugs (02.09.2022)
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Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis
Feldman, Steven R, Reznichenko, Nataliya, Berti, Fausto, Duijzings, Paul, Ruffieux, Ruth, Otto, Hendrik, Haliduola, Halimu N, Leutz, Steffen, Stroissnig, Heimo
Published in Expert opinion on biological therapy (03.08.2023)
Published in Expert opinion on biological therapy (03.08.2023)
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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, Christopher, Schwabe, Christian, Stroissnig, Heimo, Dias, Roshan, Sobierska, Joanna, Guenzi, Eric, Otto, Hendrik, Sattar, Abid, Haliduola, Halimu N, Edwald, Elin, Berti, Fausto
Published in Expert opinion on biological therapy (03.08.2023)
Published in Expert opinion on biological therapy (03.08.2023)
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Assessment of real-life patient handling experience of AVT02 administered subcutaneously via autoinjector in patients with moderate to severe active rheumatoid arthritis: an open-label, single-arm clinical trial, then an extension phase of AVT02 administered with a prefilled syringe
Damjanov, Nemanja, Kirvalidze, Nana, Kurashvili, Nana, Berti, Fausto, Steiger, Matjaz, Sobierska, Joanna, Guenzi, Eric, Otto, Hendrik, Sattar, Abid, Haliduola, Halimu N., Edwald, Elin, Stroissnig, Heimo
Published in Expert opinion on biological therapy (03.08.2023)
Published in Expert opinion on biological therapy (03.08.2023)
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Assessing the Interchangeability of AVT02 and Humira® in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study
Feldman, Steven R., Kay, Richard, Reznichenko, Nataliya, Sobierska, Joanna, Dias, Roshan, Otto, Hendrik, Haliduola, Halimu N., Sattar, Abid, Ruffieux, Ruth, Stroissnig, Heimo, Berti, Fausto
Published in BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy (01.07.2023)
Published in BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy (01.07.2023)
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Ex vivo comparative immunogenicity assessment (EVCIA) to determine relative immunogenicity in chronic plaque psoriasis in participants receiving Humira® or undergoing repeated switches between Humira® and AVT02
Richter, Kathleen, Haliduola, Halimu N, Schockaert, Jana, Mazy, Aurélie, Reznichenko, Nataliya, Guenzi, Eric, Berti, Fausto
Published in Immunotherapy advances (01.01.2024)
Published in Immunotherapy advances (01.01.2024)
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Efficacy, Safety and Immunogenicity of AVT02 Versus Originator Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis: A Multicentre, Double-Blind, Randomised, Parallel Group, Active Control, Phase III Study
Feldman, Steven R., Reznichenko, Nataliya, Pulka, Grazyna, Kingo, Külli, George Galdava, Berti, Fausto, Sobierska, Joanna, Dias, Roshan, Guenzi, Eric, Hendrik Otto, Haliduola, Halimu N., Kay, Richard, Stroissnig, Heimo
Published in BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy (01.11.2021)
Published in BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy (01.11.2021)
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Induction of apoptosis in two human leukemia cell lines as well as differentiation in human promyelocytic cells by cyanidin-3- O-β-glucopyranoside
Fimognari, Carmela, Berti, Fausto, Nüsse, Michael, Cantelli-Forti, Giorgio, Hrelia, Patrizia
Published in Biochemical pharmacology (01.06.2004)
Published in Biochemical pharmacology (01.06.2004)
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Isothiocyanates as novel cytotoxic and cytostatic agents: molecular pathway on human transformed and non-transformed cells
Fimognari, Carmela, Nüsse, Michael, Berti, Fausto, Iori, Renato, Cantelli-Forti, Giorgio, Hrelia, Patrizia
Published in Biochemical pharmacology (15.09.2004)
Published in Biochemical pharmacology (15.09.2004)
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Sulforaphane Modulates Cell Cycle and Apoptosis in Transformed and Non-transformed Human T Lymphocytes
FIMOGNARI, CARMELA, NÜSSE, MICHAEL, BERTI, FAUSTO, IORI, RENATO, CANTELLI-FORTI, GIORGIO, HRELIA, PATRIZIA
Published in Annals of the New York Academy of Sciences (01.12.2003)
Published in Annals of the New York Academy of Sciences (01.12.2003)
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