Spotting DILI (Drug-Induced Liver Injury) for FDA ... - PhUSE Wiki
Spotting DILI (Drug-Induced Liver Injury) for FDA ... - PhUSE Wiki
Spotting DILI (Drug-Induced Liver Injury) for FDA ... - PhUSE Wiki
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<strong>DILI</strong> in an <strong>FDA</strong> submission<br />
Overview<br />
" No CDISC submission<br />
" <strong>DILI</strong> analysis as part of safety<br />
" Deliverables:<br />
• eDISH peak ALT/AST - peak TBL plot<br />
• Listing showing Lab-values over time<br />
• Patient narratives<br />
Click <strong>for</strong> example document<br />
Nicola Tambascia, Accovion GmbH, 17 October 2012 13
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