FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2035029883> ?p ?o ?g. }

• W2035029883 endingPage "71" @default.
• W2035029883 startingPage "64" @default.
• W2035029883 abstract "Recombinant human interferon-beta (IFN-b) is a well-established treatment for multiple sclerosis (MS). The regulatory process for marketing authorization of biosimilars is currently under debate in certain countries. In the EU, EMEA has clearly defined the process including overarching and product-specific guidelines, which includes clinical testing. Biosimilarity needs to be based on comparability criteria, including at least molecular characterization, biological activity relevant for the therapeutic effect and relative bioavailability (bioequivalence). In the case of such complex diseases as MS, where the effect of treatment is not so directly measurable, in vitro tools can provide additional data to support comparability. Genomic microarrays assays might be useful to compare multisource biopharmaceuticals. The aim of the present study was to compare the pharmacodynamic genomic effects (in terms of transcriptional regulation) of two recombinant human IFN-I(2)1a preparations on lymphocytes of multiple sclerosis patients using a whole genome microarray assay.We performed an ex vivo whole genome expression profiling of the effect of two preparations of IFN-I(2)1a on non-adherent mononuclears from five relapsing-remitting MS patients analyzing microarrays (CodeLink Human Whole Genome). Patients blood was drawn, PBMCs isolated and cultured in three different conditions: culture medium (control), 1,000 U/ml of IFN-I(2)1a (BLA- (STOFERON, Bio Sidus) and 1,000 U/ml of IFN-I(2)1a (REBIF, Serono) RNA was purified from non-adherent cells (mostly lymphocytes), amplified and hybridized. Raw data were generated by CodeLink proprietary software. Data normalization, quality control and analysis of differential gene expression between treatments were done using linear model for microarray data. Functional annotation analysis of IFN-I(2)1a MS treatment transcription was done using DAVID.Out of the approximately 45,000 human sequences examined, no evidence of differential regulation was found when both treatments were compared (minimum adjusted p-value > 0.999). The IFN-I(2)1a effect differentially regulated the expression of 868 genes. The expression of standard markers such as GTP cyclohidrolase, MxA, and OAS isoenzymes A and B changed as a consequence of the action of IFN-I(2)1a.This exhaustive and highly sensitive assay did not show differences in the genomic expression profile of these two products under the assayed experimental conditions. These results suggest that this technology might be useful for the initial comparison of biosimilars, being part of a comprehensive comparability program that includes clinical testing." @default.
• W2035029883 created "2016-06-24" @default.
• W2035029883 creator A5000458562 @default.
• W2035029883 creator A5006071305 @default.
• W2035029883 creator A5007747769 @default.
• W2035029883 creator A5020658277 @default.
• W2035029883 creator A5035774916 @default.
• W2035029883 creator A5037103254 @default.
• W2035029883 creator A5037720412 @default.
• W2035029883 creator A5044110550 @default.
• W2035029883 creator A5056738722 @default.
• W2035029883 creator A5063738353 @default.
• W2035029883 creator A5077106900 @default.
• W2035029883 creator A5082398078 @default.
• W2035029883 date "2008-02-01" @default.
• W2035029883 modified "2023-10-05" @default.
• W2035029883 title "Two recombinant human interferon-beta 1a pharmaceutical preparations produce a similar transcriptional response determined using whole genome microarray analysis" @default.
• W2035029883 doi "https://doi.org/10.5414/cpp46064" @default.
• W2035029883 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/18218286" @default.
• W2035029883 hasPublicationYear "2008" @default.
• W2035029883 type Work @default.
• W2035029883 sameAs 2035029883 @default.
• W2035029883 citedByCount "13" @default.
• W2035029883 countsByYear W20350298832012 @default.
• W2035029883 countsByYear W20350298832015 @default.
• W2035029883 countsByYear W20350298832017 @default.
• W2035029883 crossrefType "journal-article" @default.
• W2035029883 hasAuthorship W2035029883A5000458562 @default.
• W2035029883 hasAuthorship W2035029883A5006071305 @default.
• W2035029883 hasAuthorship W2035029883A5007747769 @default.
• W2035029883 hasAuthorship W2035029883A5020658277 @default.
• W2035029883 hasAuthorship W2035029883A5035774916 @default.
• W2035029883 hasAuthorship W2035029883A5037103254 @default.
• W2035029883 hasAuthorship W2035029883A5037720412 @default.
• W2035029883 hasAuthorship W2035029883A5044110550 @default.
• W2035029883 hasAuthorship W2035029883A5056738722 @default.
• W2035029883 hasAuthorship W2035029883A5063738353 @default.
• W2035029883 hasAuthorship W2035029883A5077106900 @default.
• W2035029883 hasAuthorship W2035029883A5082398078 @default.
• W2035029883 hasBestOaLocation W20350298832 @default.
• W2035029883 hasConcept C104317684 @default.
• W2035029883 hasConcept C150194340 @default.
• W2035029883 hasConcept C186836561 @default.
• W2035029883 hasConcept C40767141 @default.
• W2035029883 hasConcept C54355233 @default.
• W2035029883 hasConcept C59491497 @default.
• W2035029883 hasConcept C70721500 @default.
• W2035029883 hasConcept C71924100 @default.
• W2035029883 hasConcept C86803240 @default.
• W2035029883 hasConcept C95371953 @default.
• W2035029883 hasConcept C98274493 @default.
• W2035029883 hasConceptScore W2035029883C104317684 @default.
• W2035029883 hasConceptScore W2035029883C150194340 @default.
• W2035029883 hasConceptScore W2035029883C186836561 @default.
• W2035029883 hasConceptScore W2035029883C40767141 @default.
• W2035029883 hasConceptScore W2035029883C54355233 @default.
• W2035029883 hasConceptScore W2035029883C59491497 @default.
• W2035029883 hasConceptScore W2035029883C70721500 @default.
• W2035029883 hasConceptScore W2035029883C71924100 @default.
• W2035029883 hasConceptScore W2035029883C86803240 @default.
• W2035029883 hasConceptScore W2035029883C95371953 @default.
• W2035029883 hasConceptScore W2035029883C98274493 @default.
• W2035029883 hasIssue "02" @default.
• W2035029883 hasLocation W20350298831 @default.
• W2035029883 hasLocation W20350298832 @default.
• W2035029883 hasLocation W20350298833 @default.
• W2035029883 hasOpenAccess W2035029883 @default.
• W2035029883 hasPrimaryLocation W20350298831 @default.
• W2035029883 hasRelatedWork W1576379437 @default.
• W2035029883 hasRelatedWork W1594655861 @default.
• W2035029883 hasRelatedWork W170658859 @default.
• W2035029883 hasRelatedWork W2041540252 @default.
• W2035029883 hasRelatedWork W2089975163 @default.
• W2035029883 hasRelatedWork W2138580185 @default.
• W2035029883 hasRelatedWork W2366558827 @default.
• W2035029883 hasRelatedWork W2415545834 @default.
• W2035029883 hasRelatedWork W3203113381 @default.
• W2035029883 hasRelatedWork W4232333928 @default.
• W2035029883 hasVolume "46" @default.
• W2035029883 isParatext "false" @default.
• W2035029883 isRetracted "false" @default.
• W2035029883 magId "2035029883" @default.
• W2035029883 workType "article" @default.