Post-marketing studies: ensuring the safety of diabetes drugs
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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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چکیده ندارد.
15 صفحه اولEfficacy and Safety of Nadifloxacin for Bacterial Skin Infections: Results from Clinical and Post-Marketing Studies
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ژورنال
عنوان ژورنال: Practical Diabetes International
سال: 2005
ISSN: 1357-8170,1528-252X
DOI: 10.1002/pdi.835