Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects.
Sign Up to like & getrecommendations! Published in 2022 at "Journal of biopharmaceutical statistics"
DOI: 10.1080/10543406.2023.2172425
Abstract: Pediatric patients should have access to medicines that have been appropriately evaluated for safety and efficacy through revised labelling. Given this goal, the adequacy of the pediatric clinical development plan and resulting safety database are… read more here.
Keywords: target effects; safety database; safety; development ... See more keywords
Hepatic safety of the antifungal triazole agent posaconazole: characterization of adverse event reports in a manufacturer’s safety database
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DOI: 10.1080/14740338.2022.2047177
Abstract: ABSTRACT Background Second generation triazoles including posaconazole are efficacious for prophylaxis and salvage treatment of life-threatening invasive fungal diseases but have been associated with hepatic adverse events (AEs). This report evaluated hepatic AEs in posaconazole-treated… read more here.
Keywords: dili concern; safety; safety database; hepatic safety ... See more keywords