A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab
Purpose!#!Bevacizumab is a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor-specific angiogenesis in some cancers. MYL-1402O is a proposed bevacizumab biosimilar.!##!Methods!#!The primary objective of this single-center, randomized, double-blind, three-arm, parallel-group, phase 1 study in healthy male volunteers was to evaluate bioequivalence of MYL-1402O to EU and US-reference bevacizumab, and EU-reference bevacizumab to US-reference bevacizumab. The primary pharmacokinetic parameter was area under the serum concentration-time curve from 0 extrapolat... Mehr ...
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Dokumenttyp: | Zeitschriftenartikel |
Erscheinungsdatum: | 2021 |
Schlagwörter: | Adolescent [MeSH] / Double-Blind Method [MeSH] / Europe [MeSH] / Therapeutic Equivalency [MeSH] / Cancer / United States [MeSH] / Adult [MeSH] / Original Article – Clinical Oncology / Biosimilar Pharmaceuticals/pharmacokinetics [MeSH] / Humans [MeSH] / Bevacizumab/pharmacokinetics [MeSH] / Monoclonal antibody / Middle Aged [MeSH] / Bevacizumab/chemistry [MeSH] / Male [MeSH] / Drug Compounding/standards [MeSH] / Pharmacokinetics / Healthy Volunteers [MeSH] / Young Adult [MeSH] / Phase 1 / Drug Compounding/methods [MeSH] / Netherlands [MeSH] / Bioequivalence / Biosimilar Pharmaceuticals/chemistry [MeSH] |
Sprache: | Englisch |
Permalink: | https://search.fid-benelux.de/Record/base-26846490 |
Datenquelle: | BASE; Originalkatalog |
Powered By: | BASE |
Link(s) : | https://repository.publisso.de/resource/frl:6449880 |