罫線.png

罫線1

250805_創薬サイエンス_バナーRGB_250-110.gif

創薬サイエンス

【AMED】日本薬学会第146年会.gif

日本医療研究開発機構

【UBE】_バナー広告_ロゴ.gif

UBE株式会社

東ソーロゴバナー（250px × 93px）.jpg

東ソー

【安井機械】banner_250x110.jpg

安井器械株式会社

【修正版】【BINDS】H110W250_日本薬学会第146年会_BINDSハ゛ナー広告_0212.png

BINDS

入稿データ_生命科学連携推進協議会.gif

生命科学連携推進協議会

General information

Overview

Access

Announcements(27)

Timetable

Fri. Mar 27, 2026

Sat. Mar 28, 2026

Sun. Mar 29, 2026

Program & Abstract

Sessions

Search presentations

Download PDF for print

Selected programs of presentations in English

Registration

Registration (Non-presenters, UG ≤ 4th Year)

Pharmaceutical International Meeting

For Participants

Participation Certificate PDF

Floor Guide

How to use "Confit mobile meeting app"

For Presenters

Exhibition

Companies（Equipment exhibits）

Companies（Medical supplies）

Companies (Literature Search Systems)

Companies（Books）

Abstract Submission (Oral/Poster Presentation)

Abstract Submission

146_head_en.png

app_icon.png

Change account information such as the email address and password on the account setting screen common to Confit.

Login required to view

Password required to view

Presentation Information

Session Details

Enter the password to view the abstracts.<br>The password will be emailed to those who have completed the registration.

To browse or post comments, you must log in.

You cannot post comments as it is outside the comment posting period.

This comment has been deleted. You cannot reply to this comment.

Program Type

General Session Category

Profile management

Bookmark

Announcements

Current status and issues to develop NAMs for specific target organ systemic toxicity

Amid growing interest in promoting the 3Rs in animal testing, New Approach Methodologies (NAMs) that do not rely on conventional animal studies are being actively explored as alternative tools for drug safety assessment. Although expectations for NAMs are increasing, accurate prediction of human safety requires a clear definition of the applicability domain of each method. In addition, rather than depending on a single approach, integrated strategies such as Integrated Approaches to Testing and Assessment (IATA) are essential. The need to develop NAMs aligned with the Concept of Use (CoU) required by end users, including pharmaceutical companies, has also been emphasized. In regulatory science, international discussions are progressing on how these technologies should be incorporated into regulatory frameworks. This symposium will begin with an overview of the current status and challenges of NAMs. Academic researchers will introduce advanced initiatives, including AI- and machine learning–based safety evaluations of drugs and chemicals, as well as new <i>in vitro</i> models for assessing biliary excretion. Furthermore, industry researchers will present applications such as drug disposition prediction using humanized-liver chimeric animals and iPS cell–based systems, along with approaches to embryo–fetal developmental toxicity assessment. Through these presentations, we aim to deepen the discussion on the potential and challenges of NAMs in drug safety research.

Rethinking Regulatory Science in Drug Safety Research

The 146th Annual Meeting of the Pharmaceutical Society of Japan (Osaka)

Presentation Information

[S47-1]Current status and issues to develop NAMs for specific target organ systemic toxicity

Password required to view