ゼブラフィッシュ発生毒性試験における品質管理プロトコルの確立

田中 利男; 小島 肇; 藤原 道夫; 森 華奈子; 山本 恭子; 山田 佳代子; 水谷 有香; 森 葵泉; 加藤 由起子

doi:10.14869/toxpt.48.1.0_O-39

The 48th Annual Meeting of the Japanese Society of Toxicology

Session ID : O-39

DOI https://doi.org/10.14869/toxpt.48.1.0_O-39

Conference information

Host: The Japanese Society of Toxicology

Oral

Quality Control Protocol for Zebrafish Developmental Toxicological Science

*Toshio TANAKA, Hajime KOJIMA, Michio FUJIWARA, Kanako MORI, Kyoko YAMAMOTO, Kayoko YAMADA, Yuka MIZUTANI, Aoi MORI, Yukiko KATO

Author information

*Toshio TANAKA
Department of Systems Pharmacology, Mie University Graduate School of Medicine
Medical Zebrafish Research Center, Mie University
Hajime KOJIMA
Division of Risk Assessment, National Institute of Health Sciences
Michio FUJIWARA
Drug Safety Research Laboratories, Astellas Pharma Inc.
Kanako MORI
Drug Safety Research Laboratories, Astellas Pharma Inc.
Kyoko YAMAMOTO
Department of Systems Pharmacology, Mie University Graduate School of Medicine
Medical Zebrafish Research Center, Mie University
Kayoko YAMADA
Department of Systems Pharmacology, Mie University Graduate School of Medicine
Medical Zebrafish Research Center, Mie University
Yuka MIZUTANI
Department of Systems Pharmacology, Mie University Graduate School of Medicine
Medical Zebrafish Research Center, Mie University
Aoi MORI
Department of Systems Pharmacology, Mie University Graduate School of Medicine
Medical Zebrafish Research Center, Mie University
Yukiko KATO
Department of Systems Pharmacology, Mie University Graduate School of Medicine
Medical Zebrafish Research Center, Mie University

CONFERENCE PROCEEDINGS FREE ACCESS

Details

Abstract

On January 29, 2021, PMDA published the DETECTION OF REPRODUCTIVE AND DEVELOPMENTAL TOXICITY FOR HUMAN PHARMACEUTICAL S5(R3) by ICH. And zebrafish developmental toxicity test as an alternative method is now in full swing in Japan. In this study, we have established a zebrafish quality control protocol, which is the most important basis for this zebrafish developmental toxicity test. We found that it was possible to remove these low-quality fertilized eggs, thereby reducing false positive frequency and enhancing the accuracy of zebrafish developmental toxicity testing.

Corresponding author

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