Consideration of post-marketing drug safety assessment in hospitals
نویسندگان
چکیده
منابع مشابه
A pre-marketing ALT signal predicts post-marketing liver safety.
Drug induced liver injury during drug development is evidenced by a higher incidence of serum alanine aminotransferase (ALT) elevations in treated versus placebo populations and termed an "ALT signal". We sought to quantify whether an ALT signal in pre-marketing clinical trials predicted post-marketing hepatotoxicity. Incidence of ALT elevations (ALT ≥ 3 times upper limits normal [× ULN]) for d...
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ژورنال
عنوان ژورنال: Proceedings for Annual Meeting of The Japanese Pharmacological Society
سال: 2018
ISSN: 2435-4953
DOI: 10.1254/jpssuppl.wcp2018.0_po3-12-11