Matches in SemOpenAlex for { <https://semopenalex.org/work/W1569176587> ?p ?o ?g. }
- W1569176587 endingPage "37" @default.
- W1569176587 startingPage "27" @default.
- W1569176587 abstract "Nonclinical safety studies are increasingly incorporating cardiac safety endpoints to discover potential cardiovascular liabilities. This trend for more thorough cardiovascular nonclinical safety evaluation is prudent given the high attrition rate of potential therapeutics due to unexpected cardiovascular liabilities discovered in late-stage clinical trials or post-market approval. In particular, the causal relationship of blood pressure changes that lead to risk of major adverse cardiac events suggests hemodynamic changes should be critically evaluated in preclinical studies of novel therapeutics.Jacketed external telemetry with an implanted miniature blood pressure transmitter (JET-BP) was used to characterize the tolerability, functionality, and sensitivity of this study design in dogs. Thirty-six male or female beagles (n=6 dogs/sex/group) were administered vehicle control (reverse osmosis water) or etilefrine (1, 10mg/kg), sotalol (3, 30mg/kg), and hydralazine (1, 10mg/kg) on separate days. Telemetry data were evaluated for positive control article-related changes and retrospective power analysis was also completed. Animals were evaluated for instrumentation-related changes in clinical and anatomic pathology endpoints.All three positive controls elicited the expected pharmacologic responses that were statistically different at high and low doses. Retrospective power analysis confirmed this study design was able to statistically differentiate minor (approximately 5 to 15%) changes in electrocardiography and blood pressure values. This study also demonstrated the potential advantages of combining cardiovascular data across sex when the test article exposure and pharmacodynamics were consistent. Data collection using miniature telemetry blood pressure transmitters did not result in anatomic or clinical pathology findings that would prevent their use in general toxicology studies.This characterization study indicates that JET-BP in dogs offers a scientifically-robust method to evaluate novel therapeutics for potential cardiovascular liabilities." @default.
- W1569176587 created "2016-06-24" @default.
- W1569176587 creator A5016608854 @default.
- W1569176587 creator A5024291506 @default.
- W1569176587 creator A5040386638 @default.
- W1569176587 creator A5059516034 @default.
- W1569176587 creator A5066532180 @default.
- W1569176587 creator A5074678453 @default.
- W1569176587 creator A5083063579 @default.
- W1569176587 date "2015-09-01" @default.
- W1569176587 modified "2023-09-26" @default.
- W1569176587 title "Evaluation of cardiovascular changes in dogs administered three positive controls using jacketed external telemetry-blood pressure (JET-BP)" @default.
- W1569176587 cites W1505816740 @default.
- W1569176587 cites W165055411 @default.
- W1569176587 cites W1780627874 @default.
- W1569176587 cites W1890263319 @default.
- W1569176587 cites W1967348830 @default.
- W1569176587 cites W1974487293 @default.
- W1569176587 cites W1975348263 @default.
- W1569176587 cites W1991460329 @default.
- W1569176587 cites W2000005501 @default.
- W1569176587 cites W2000567608 @default.
- W1569176587 cites W2000680464 @default.
- W1569176587 cites W2002310806 @default.
- W1569176587 cites W2016913639 @default.
- W1569176587 cites W2019731599 @default.
- W1569176587 cites W2026904409 @default.
- W1569176587 cites W2037243689 @default.
- W1569176587 cites W2039802311 @default.
- W1569176587 cites W2040165440 @default.
- W1569176587 cites W2042677320 @default.
- W1569176587 cites W2053359053 @default.
- W1569176587 cites W2058126990 @default.
- W1569176587 cites W2062853736 @default.
- W1569176587 cites W2075755061 @default.
- W1569176587 cites W2078238290 @default.
- W1569176587 cites W2085559415 @default.
- W1569176587 cites W2085806949 @default.
- W1569176587 cites W2089539307 @default.
- W1569176587 cites W2098196515 @default.
- W1569176587 cites W2104209550 @default.
- W1569176587 cites W2105143262 @default.
- W1569176587 cites W2120807317 @default.
- W1569176587 cites W2126112930 @default.
- W1569176587 cites W4232424793 @default.
- W1569176587 doi "https://doi.org/10.1016/j.vascn.2015.05.008" @default.
- W1569176587 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/26001324" @default.
- W1569176587 hasPublicationYear "2015" @default.
- W1569176587 type Work @default.
- W1569176587 sameAs 1569176587 @default.
- W1569176587 citedByCount "9" @default.
- W1569176587 countsByYear W15691765872015 @default.
- W1569176587 countsByYear W15691765872016 @default.
- W1569176587 countsByYear W15691765872017 @default.
- W1569176587 countsByYear W15691765872018 @default.
- W1569176587 countsByYear W15691765872021 @default.
- W1569176587 countsByYear W15691765872022 @default.
- W1569176587 countsByYear W15691765872023 @default.
- W1569176587 crossrefType "journal-article" @default.
- W1569176587 hasAuthorship W1569176587A5016608854 @default.
- W1569176587 hasAuthorship W1569176587A5024291506 @default.
- W1569176587 hasAuthorship W1569176587A5040386638 @default.
- W1569176587 hasAuthorship W1569176587A5059516034 @default.
- W1569176587 hasAuthorship W1569176587A5066532180 @default.
- W1569176587 hasAuthorship W1569176587A5074678453 @default.
- W1569176587 hasAuthorship W1569176587A5083063579 @default.
- W1569176587 hasConcept C126322002 @default.
- W1569176587 hasConcept C127413603 @default.
- W1569176587 hasConcept C146978453 @default.
- W1569176587 hasConcept C164705383 @default.
- W1569176587 hasConcept C178853913 @default.
- W1569176587 hasConcept C183121708 @default.
- W1569176587 hasConcept C197934379 @default.
- W1569176587 hasConcept C2776190711 @default.
- W1569176587 hasConcept C2777953023 @default.
- W1569176587 hasConcept C2778375690 @default.
- W1569176587 hasConcept C2780035454 @default.
- W1569176587 hasConcept C42219234 @default.
- W1569176587 hasConcept C71924100 @default.
- W1569176587 hasConcept C84393581 @default.
- W1569176587 hasConcept C98274493 @default.
- W1569176587 hasConceptScore W1569176587C126322002 @default.
- W1569176587 hasConceptScore W1569176587C127413603 @default.
- W1569176587 hasConceptScore W1569176587C146978453 @default.
- W1569176587 hasConceptScore W1569176587C164705383 @default.
- W1569176587 hasConceptScore W1569176587C178853913 @default.
- W1569176587 hasConceptScore W1569176587C183121708 @default.
- W1569176587 hasConceptScore W1569176587C197934379 @default.
- W1569176587 hasConceptScore W1569176587C2776190711 @default.
- W1569176587 hasConceptScore W1569176587C2777953023 @default.
- W1569176587 hasConceptScore W1569176587C2778375690 @default.
- W1569176587 hasConceptScore W1569176587C2780035454 @default.
- W1569176587 hasConceptScore W1569176587C42219234 @default.
- W1569176587 hasConceptScore W1569176587C71924100 @default.
- W1569176587 hasConceptScore W1569176587C84393581 @default.
- W1569176587 hasConceptScore W1569176587C98274493 @default.
- W1569176587 hasLocation W15691765871 @default.
- W1569176587 hasLocation W15691765872 @default.