Matches in SemOpenAlex for { <https://semopenalex.org/work/W3039580108> ?p ?o ?g. }
Showing items 1 to 68 of
68
with 100 items per page.
- W3039580108 abstract "Abstract Translational safety biomarkers are responsive across nonclinical species where toxicity is directly correlated with histopathology; in humans, where histopathological assessment is not feasible, biomarker response is correlated with current standard biomarker response and clinical adjudication for tissue injury. Clinical scientists are nearly exclusively reliant on safety biomarkers to assess drug-induced tissue injury in clinical trials. It is therefore critical that safety biomarkers are deemed reliable for clinical decision-making and patient safety. Biomarker qualification is the formal regulatory acceptance of a biomarker for a specific context of use. Qualification results in certainty as to how the biomarker can be applied and how the biomarker data generated in drug development programs should be interpreted by both drug developers and regulators." @default.
- W3039580108 created "2020-07-10" @default.
- W3039580108 creator A5023833134 @default.
- W3039580108 creator A5088120714 @default.
- W3039580108 date "2020-10-01" @default.
- W3039580108 modified "2023-09-24" @default.
- W3039580108 title "The regulatory acceptance of translational safety biomarkers" @default.
- W3039580108 cites W2031292272 @default.
- W3039580108 cites W2164819474 @default.
- W3039580108 cites W2173982264 @default.
- W3039580108 cites W2768386871 @default.
- W3039580108 doi "https://doi.org/10.1016/j.cotox.2020.06.001" @default.
- W3039580108 hasPublicationYear "2020" @default.
- W3039580108 type Work @default.
- W3039580108 sameAs 3039580108 @default.
- W3039580108 citedByCount "1" @default.
- W3039580108 countsByYear W30395801082021 @default.
- W3039580108 crossrefType "journal-article" @default.
- W3039580108 hasAuthorship W3039580108A5023833134 @default.
- W3039580108 hasAuthorship W3039580108A5088120714 @default.
- W3039580108 hasConcept C104317684 @default.
- W3039580108 hasConcept C124535831 @default.
- W3039580108 hasConcept C128544194 @default.
- W3039580108 hasConcept C142724271 @default.
- W3039580108 hasConcept C151730666 @default.
- W3039580108 hasConcept C2779343474 @default.
- W3039580108 hasConcept C2780035454 @default.
- W3039580108 hasConcept C2781197716 @default.
- W3039580108 hasConcept C46111723 @default.
- W3039580108 hasConcept C535046627 @default.
- W3039580108 hasConcept C55493867 @default.
- W3039580108 hasConcept C64903051 @default.
- W3039580108 hasConcept C71924100 @default.
- W3039580108 hasConcept C86803240 @default.
- W3039580108 hasConcept C98274493 @default.
- W3039580108 hasConceptScore W3039580108C104317684 @default.
- W3039580108 hasConceptScore W3039580108C124535831 @default.
- W3039580108 hasConceptScore W3039580108C128544194 @default.
- W3039580108 hasConceptScore W3039580108C142724271 @default.
- W3039580108 hasConceptScore W3039580108C151730666 @default.
- W3039580108 hasConceptScore W3039580108C2779343474 @default.
- W3039580108 hasConceptScore W3039580108C2780035454 @default.
- W3039580108 hasConceptScore W3039580108C2781197716 @default.
- W3039580108 hasConceptScore W3039580108C46111723 @default.
- W3039580108 hasConceptScore W3039580108C535046627 @default.
- W3039580108 hasConceptScore W3039580108C55493867 @default.
- W3039580108 hasConceptScore W3039580108C64903051 @default.
- W3039580108 hasConceptScore W3039580108C71924100 @default.
- W3039580108 hasConceptScore W3039580108C86803240 @default.
- W3039580108 hasConceptScore W3039580108C98274493 @default.
- W3039580108 hasFunder F4320332163 @default.
- W3039580108 hasLocation W30395801081 @default.
- W3039580108 hasOpenAccess W3039580108 @default.
- W3039580108 hasPrimaryLocation W30395801081 @default.
- W3039580108 hasRelatedWork W10691706 @default.
- W3039580108 hasRelatedWork W11093380 @default.
- W3039580108 hasRelatedWork W18500874 @default.
- W3039580108 hasRelatedWork W18791568 @default.
- W3039580108 hasRelatedWork W19929880 @default.
- W3039580108 hasRelatedWork W2657376 @default.
- W3039580108 hasRelatedWork W4652445 @default.
- W3039580108 hasRelatedWork W5931327 @default.
- W3039580108 hasRelatedWork W7409531 @default.
- W3039580108 hasRelatedWork W7938798 @default.
- W3039580108 isParatext "false" @default.
- W3039580108 isRetracted "false" @default.
- W3039580108 magId "3039580108" @default.
- W3039580108 workType "article" @default.