FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4308444914> ?p ?o ?g. }

• W4308444914 endingPage "1428" @default.
• W4308444914 startingPage "1417" @default.
• W4308444914 abstract "Background Inclacumab is a recombinant, fully human, immunoglobulin IgG4 monoclonal antibody that selectively binds to P-selectin. Initially discovered and developed by Roche through phase 2 clinical studies in peripheral arterial disease and coronary artery disease, inclacumab has been in-licensed by Global Blood Therapeutics (GBT) as a potential treatment to reduce the frequency of vaso-occlusive crises in individuals with sickle cell disease.Research design and methods GBT sought to demonstrate the analytical comparability between material produced by Roche and material produced by GBT to ensure that no meaningful differences in identity, safety, purity, potency, or bioavailability exist between the GBT and Roche lots.Results Inclacumab samples produced by GBT were found to be comparable to the Roche v0.2 inclacumab samples based on (1) comparable primary and higher-order structures; (2) comparable purity profiles; (3) comparable potency, in vitro functional activities, and in vivo plasma exposures and pharmacokinetic profiles; and (4) comparable degradation patterns and kinetics under forced degradation conditions.Conclusions Based on the design of this comparability study and the results obtained, the US Food and Drug Administration approved the changes to the manufacturing process and gave clearance for GBT to proceed with phase 3 clinical trials." @default.
• W4308444914 created "2022-11-11" @default.
• W4308444914 creator A5009481374 @default.
• W4308444914 creator A5015062209 @default.
• W4308444914 creator A5033286474 @default.
• W4308444914 creator A5047694805 @default.
• W4308444914 creator A5048385883 @default.
• W4308444914 creator A5057592171 @default.
• W4308444914 creator A5065672459 @default.
• W4308444914 creator A5067389539 @default.
• W4308444914 creator A5076280740 @default.
• W4308444914 creator A5087486639 @default.
• W4308444914 date "2022-11-02" @default.
• W4308444914 modified "2023-09-26" @default.
• W4308444914 title "Analytical comparability demonstrated for an IgG4 molecule, inclacumab, following transfer of manufacturing responsibility from Roche to Global Blood Therapeutics" @default.
• W4308444914 cites W1512569924 @default.
• W4308444914 cites W1584253018 @default.
• W4308444914 cites W1935749840 @default.
• W4308444914 cites W1966853009 @default.
• W4308444914 cites W1970844304 @default.
• W4308444914 cites W2001607896 @default.
• W4308444914 cites W203611039 @default.
• W4308444914 cites W2039870425 @default.
• W4308444914 cites W2053495832 @default.
• W4308444914 cites W2075781353 @default.
• W4308444914 cites W2137354517 @default.
• W4308444914 cites W2489311180 @default.
• W4308444914 cites W2559643145 @default.
• W4308444914 cites W2791987218 @default.
• W4308444914 cites W2912324466 @default.
• W4308444914 cites W4211186710 @default.
• W4308444914 doi "https://doi.org/10.1080/14712598.2022.2143260" @default.
• W4308444914 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/36342398" @default.
• W4308444914 hasPublicationYear "2022" @default.
• W4308444914 type Work @default.
• W4308444914 citedByCount "2" @default.
• W4308444914 countsByYear W43084449142023 @default.
• W4308444914 crossrefType "journal-article" @default.
• W4308444914 hasAuthorship W4308444914A5009481374 @default.
• W4308444914 hasAuthorship W4308444914A5015062209 @default.
• W4308444914 hasAuthorship W4308444914A5033286474 @default.
• W4308444914 hasAuthorship W4308444914A5047694805 @default.
• W4308444914 hasAuthorship W4308444914A5048385883 @default.
• W4308444914 hasAuthorship W4308444914A5057592171 @default.
• W4308444914 hasAuthorship W4308444914A5065672459 @default.
• W4308444914 hasAuthorship W4308444914A5067389539 @default.
• W4308444914 hasAuthorship W4308444914A5076280740 @default.
• W4308444914 hasAuthorship W4308444914A5087486639 @default.
• W4308444914 hasBestOaLocation W43084449141 @default.
• W4308444914 hasConcept C112705442 @default.
• W4308444914 hasConcept C114614502 @default.
• W4308444914 hasConcept C150903083 @default.
• W4308444914 hasConcept C159654299 @default.
• W4308444914 hasConcept C181389837 @default.
• W4308444914 hasConcept C185592680 @default.
• W4308444914 hasConcept C197947376 @default.
• W4308444914 hasConcept C202751555 @default.
• W4308444914 hasConcept C203014093 @default.
• W4308444914 hasConcept C207001950 @default.
• W4308444914 hasConcept C33923547 @default.
• W4308444914 hasConcept C542903549 @default.
• W4308444914 hasConcept C55493867 @default.
• W4308444914 hasConcept C57992300 @default.
• W4308444914 hasConcept C71924100 @default.
• W4308444914 hasConcept C86803240 @default.
• W4308444914 hasConcept C98274493 @default.
• W4308444914 hasConceptScore W4308444914C112705442 @default.
• W4308444914 hasConceptScore W4308444914C114614502 @default.
• W4308444914 hasConceptScore W4308444914C150903083 @default.
• W4308444914 hasConceptScore W4308444914C159654299 @default.
• W4308444914 hasConceptScore W4308444914C181389837 @default.
• W4308444914 hasConceptScore W4308444914C185592680 @default.
• W4308444914 hasConceptScore W4308444914C197947376 @default.
• W4308444914 hasConceptScore W4308444914C202751555 @default.
• W4308444914 hasConceptScore W4308444914C203014093 @default.
• W4308444914 hasConceptScore W4308444914C207001950 @default.
• W4308444914 hasConceptScore W4308444914C33923547 @default.
• W4308444914 hasConceptScore W4308444914C542903549 @default.
• W4308444914 hasConceptScore W4308444914C55493867 @default.
• W4308444914 hasConceptScore W4308444914C57992300 @default.
• W4308444914 hasConceptScore W4308444914C71924100 @default.
• W4308444914 hasConceptScore W4308444914C86803240 @default.
• W4308444914 hasConceptScore W4308444914C98274493 @default.
• W4308444914 hasIssue "11" @default.
• W4308444914 hasLocation W43084449141 @default.
• W4308444914 hasLocation W43084449142 @default.
• W4308444914 hasOpenAccess W4308444914 @default.
• W4308444914 hasPrimaryLocation W43084449141 @default.
• W4308444914 hasRelatedWork W1906640546 @default.
• W4308444914 hasRelatedWork W1971244395 @default.
• W4308444914 hasRelatedWork W2028112905 @default.
• W4308444914 hasRelatedWork W2080955156 @default.
• W4308444914 hasRelatedWork W2379311614 @default.
• W4308444914 hasRelatedWork W2400119402 @default.
• W4308444914 hasRelatedWork W2582907174 @default.
• W4308444914 hasRelatedWork W2606334551 @default.
• W4308444914 hasRelatedWork W2753834235 @default.
• W4308444914 hasRelatedWork W4210842440 @default.

• next