Post-authorization safety study of Betaine anhydrous.
Sign Up to like & getrecommendations! Published in 2022 at "Journal of inherited metabolic disease"
DOI: 10.1002/jimd.12499
Abstract: Patient registries for rare diseases enable systematic data collection and can also be used to facilitate post-authorization safety studies (PASS) for orphan drugs. This study evaluates the PASS for betaine anhydrous (Cystadane®), conducted as public… read more here.
Keywords: authorization safety; authorization; betaine anhydrous; deficiency ... See more keywords
Lessons learned from a multi‐data source research collaboration: The mirabegron post‐authorization safety study program
Sign Up to like & getrecommendations! Published in 2024 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.5799
Abstract: Many factors contribute to developing and conducting a successful multi‐data source, non‐interventional, post‐authorization safety study (NI‐PASS) for submission to multiple health authorities. Such studies are often large undertakings; evaluating and sharing lessons learned can provide… read more here.
Keywords: safety study; multi data; authorization safety; post authorization ... See more keywords