Retrospective analysis of the in vitro screening process for detecting DILI liability using Takeda legacy compounds

MIYAMOTO Makoto, AMANO Yuichiro, ANAYAMA Hisashi, DRAGAN Yvonne P

doi:10.14869/toxpt.47.1.0_s18-4

Bibliographic Information

Other Title

DILI懸念を検出するためのin vitroスクリーニングプロセスの自社化合物を用いた遡及的分析

Abstract

Drug-induced liver injury (DILI) is a significant public health problem that has a critical impact on not only patients but also healthcare professionals, pharmaceutical companies and regulatory authorities. It is considered difficult to predict its occurrence due to a complex interaction between chemical properties and patient factors.Recent technological advances have led to the development of in vitro assays that can improve the predictability of clinical adverse events, and they are now becoming available in the early stages of drug discovery. Based on the concept of "Safety by Design", we have adopted a tiered approach that is stepwise approach from "a simple and high-throughput assay system" to "a complex assay system focused on organ toxicity". Recently we re-evaluated Takeda legacy compounds including lapaquistat which has been terminated in phase III due to safety concerns in the liver, by the DILI-related assays introduced in the tiered approach, as part of evaluation of the usefulness of these assays for DILI prediction.In this symposium, we will report the results and would like to discuss the future challenge to improve the predictability of clinical DILI.

Journal

Annual Meeting of the Japanese Society of Toxicology

Annual Meeting of the Japanese Society of Toxicology 47.1 (0), S18-4-, 2020

The Japanese Society of Toxicology

Details 詳細情報について

CRID: 1390848647545152384

NII Article ID: 130007898476

DOI: 10.14869/toxpt.47.1.0_s18-4

Text Lang: ja

Data Source

JaLC
CiNii Articles

Abstract License Flag: Disallowed

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