Articles with "post authorization" as a keyword



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Post-authorization safety study of Betaine anhydrous.

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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