eDISH (evaluation of Drug-Induced Serious Hepatotoxicity) is a well described method/tool that visually represent liver laboratory data of ALT/AST and Total Bilirubin in form of graph by displaying peak levels for each subject. This is often known as. eDISH plots. Relevant ULN (Upper Limit of Normal) value and treatment arm data.

2025年3月4日 · 本文将通过一个实用的 SAS 工具——eDISH 图（Evaluation of Drug-Induced Serious Hepatotoxicity），深入探讨如何轻松应对药物肝毒性挑战。 本文由数据科学家 徐霖霖 编写，并由医学总监 Bob Lau 审核，确保内容的专业性和准确性。

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. The author reveals some important technical details of eDISH.

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. We believe eDISH should become a standard …

In this paper we are providing details for Hy's law related eDISH (Evaluation of Drug-Induced Serious Hepatotoxicity) plot which is not so common across clinical trial data analyses. It is mostly used for examining serious hepatotoxicity.

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 ...

2018年3月21日 · The eDISH program was intended for use in clinical trials by FDA medical reviewers, but has been copied and widely misunderstood. The first step ALTxTBL plot does NOT define a Hy’s law case; to do so requires making a medical differential diagnosis of probable drug cause. The eDISH program is NOT simply a graph of serum chemistry elevations.

为进一步指导评估药物临床试验中药物性肝损伤（Drug-Induced Liver Injury，DILI）的潜在可能性，保障受试者安全，同时获得安全性信息以评估试验药物的风险特征，2022年10月8日，国家药品监督管理局药品审评中心（CDE）官网发布《临床试验中药物性肝损伤的识别、处理及评价指导原则》（征求意见稿）；2023年7月10日，CDE官网发布 《临床试验中的药物性肝损伤识别、处理及评价指导原则》 （成文日期：2023年7月7日），自发布之日起实施。 本指导原则提出了药物 …

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.

2012年11月21日 · The eDISH plot allowed simultaneous display of the peak ALT and TB from all subjects enrolled in the clinical trials. The division into four quadrants allowed immediate comparison of the effects of rivaroxaban versus enoxaparin in terms of serum elevations in ALT greater than three times the ULN or TB levels exceeding twice the ULN.