Missing data imputation using utility-based regression and sampling approaches
Haliduola, Halimu N., Bretz, Frank, Mansmann, Ulrich
Published in Computer methods and programs in biomedicine (01.11.2022)
Published in Computer methods and programs in biomedicine (01.11.2022)
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Journal Article
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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Journal Article
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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Journal Article
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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Journal Article
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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Journal Article
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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Journal Article
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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Journal Article
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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Journal Article
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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Journal Article
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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Journal Article
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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Journal Article