What is eDISH ? eDISH= evaluation of Drug-Induced Serious Hepatotoxicity •It is one of the analysis method to assess “Liver Safety Data” for any investigational product. •eDISH is very useful approach that organizes liver laboratory data by graphically displaying peak serum ALT (Alanine transaminase)and TB (Total Bilirubin)

2011年3月1日 · The eDISH approach is an efficient and effective way to organize and examine large liver safety databases for randomized controlled clinical trials. It greatly facilitates a systematic and transparent examination of the relevant liver safety laboratory data.

Figure 1. eDISH, Evalua-tion of Drug-Induced Seri-ous Hepatotoxicity. eDISH plot showing peak ALT and TBL levels from a database of a phase 3 clinical trial. Over repre-sentation of points on study drug in the Hy’s Law range quadrant and the Temple’s Corollary range quadrant suggests a pos-sible increased risk of severe DILI. ALT, alanine

2012年11月21日 · The eDISH tool was conceptualized by Dr John Senior at the FDA to allow medical reviewers to display the peak serum ALT and TB values for every subject in a clinical trial. eDISH allows each point in the display to be directly linked to all liver chemistry values obtained for that subject, as well as other pertinent clinical data. Medical ...

The Evaluation of Drug‐Induced Serious Hepatotoxicity (eDISH) plot, another widely used hepatic safety assessment tool by regulators and drug developers, allows scanning of large numbers of clinical trial patients for indicators of hepatocellular injury by serum ALT and TBL levels.

This tool, named eDISH (Evaluation of Drug Induced Serious Hepatotoxicity) now is used by FDA scientists for their regulatory reviews of new drug applications (NDA). The eDISH tool was created using SAS/IntrNet and Application Dispatcher’s Application Broker.

2014年5月28日 · To improve the reporting and detection of Hy’s law cases in clinical trial database, the FDA has recently introduced the Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) plot, which was developed by Drs Guo and Senior at the FDA to allow medical reviewers to display the peak serum ALT and TBL values for every clinical trial subject ...

2014年10月29日 · As long as that data is not available, it is proposed to assess liver chemistries using graphical depictions of both ULN corrected data (eDISH) and modified eDISH (mDISH) for baseline corrected data, as complementary methods.

(ALP). eDISH (evaluation of Drug-Induced Serious Hepatotoxicity) is a recently described tool that organizes liver laboratory data by graphically displaying peak serum ALT and TB levels for each subject, and can also provide direct links to the pertinent clinical and …

2016年10月17日 · The Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) plot, another widely used hepatic safety assessment tool by regulators, was designed originally for patients without preexisting CLD who are enrolled into clinical trials with healthy livers. 6 The eDISH plot has been developed by Guo and Senior of the FDA as a simple and efficient ...