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eDISH – A tool for DILI evaluation

Source of picture: [1], page 14

Nicola Tambascia, Accovion GmbH, 17 October 2012 12

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eDISH – A tool for DILI evaluation Source of picture: [1], page 14 Nicola Tambascia, Accovion GmbH, 17 October 2012 12

DILI in an FDA submission Overview " No CDISC submission " DILI analysis as part of safety " Deliverables: • eDISH peak ALT/AST - peak TBL plot • Listing showing Lab-values over time • Patient narratives Click for example document Nicola Tambascia, Accovion GmbH, 17 October 2012 13

Page 1 and 2: Spotting DILI (Drug-Induced Liver I
Page 3 and 4: Drug-induced liver injury What is D
Page 5 and 6: Drug-induced liver injury Spotting
Page 7 and 8: Hy’s Law Major indicators of a po
Page 9 and 10: Hy’s Law Hy’s Law and the submi
Page 11: eDISH - A tool for DILI evaluation
Page 15: Thank you for your attention! Nicol

Spotting DILI (Drug-Induced Liver Injury) for FDA ... - PhUSE Wiki

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