核酸医薬品の非臨床安全性評価における疑問と考え方について

太田 哲也; 木下 潔; 三井田 宏明; 花田 智彦; 高井 有一; 吉岡 智子; 近藤 聡志; 熊田 幸平; 鵜川 徹; 鳥塚 尚樹; 本山 径子; 齊藤 理央; 渡部 一人; 平林 容子; 真木 一茂; 笛木 修

doi:10.51018/pmdrs.53.3_211

[title in Japanese]

Tetsuya Ohta, Kiyoshi Kinoshita, Hiroaki Miida, Tomohiko Hanada, Yuuichi Takai, Satoko Yoshioka, Satoshi Kondo, Kouhei Kumada, Tohru Ugawa, Naoki Toritsuka, Keiko Motoyama, Rio Saito, Kazuto Watanabe, Yoko Hirabayashi, Kazushige Maki, Osamu Fueki

Author information

Tetsuya Ohta
Japan Pharmaceutical Manufacturers Association, Non-clinical safety working team on innovative pharmaceutical and medical technology
Mitsubishi Tanabe Pharma Co.
Kiyoshi Kinoshita
Japan Pharmaceutical Manufacturers Association, Non-clinical safety working team on innovative pharmaceutical and medical technology
Working Group for the ICH S6 & Related Issues
MSD K.K.
Hiroaki Miida
Japan Pharmaceutical Manufacturers Association, Non-clinical safety working team on innovative pharmaceutical and medical technology
Daiichi Sankyo Co., Ltd.
Tomohiko Hanada
Japan Pharmaceutical Manufacturers Association, Non-clinical safety working team on innovative pharmaceutical and medical technology
Nippon Shinyaku Co., Ltd.
Yuuichi Takai
Japan Pharmaceutical Manufacturers Association, Non-clinical safety working team on innovative pharmaceutical and medical technology
Takeda Pharmaceutical Company Ltd.
Satoko Yoshioka
Japan Pharmaceutical Manufacturers Association, Non-clinical safety working team on innovative pharmaceutical and medical technology
Takeda Pharmaceutical Company Ltd.
Satoshi Kondo
Japan Pharmaceutical Manufacturers Association, Non-clinical safety working team on innovative pharmaceutical and medical technology
Otsuka Pharmaceutical Co., Ltd.
Kouhei Kumada
Japan Pharmaceutical Manufacturers Association, Non-clinical safety working team on innovative pharmaceutical and medical technology
Toa Eiyo Ltd.
Tohru Ugawa
Japan Pharmaceutical Manufacturers Association, Non-clinical safety working team on innovative pharmaceutical and medical technology
Astellas Pharma Inc.
Naoki Toritsuka
Japan Pharmaceutical Manufacturers Association, Non-clinical safety working team on innovative pharmaceutical and medical technology
Bristol-Myers Squibb K.K.
Keiko Motoyama
Japan Pharmaceutical Manufacturers Association, Non-clinical safety working team on innovative pharmaceutical and medical technology
Janssen Pharmaceutical K.K.
Rio Saito
Japan Pharmaceutical Manufacturers Association, Non-clinical safety working team on innovative pharmaceutical and medical technology
FUJIFILM Toyama Chemical Co., Ltd
Kazuto Watanabe
Japan Pharmaceutical Manufacturers Association, Non-clinical safety working team on innovative pharmaceutical and medical technology
Working Group for the ICH S6 & Related Issues
Japan Pharmaceutical Manufacturing Association（ JPMA）
Yoko Hirabayashi
Working Group for the ICH S6 & Related Issues
National Institute of Health Sciences
Kazushige Maki
Working Group for the ICH S6 & Related Issues
Pharmaceuticals and Medical Devices Agency（ PMDA）
Osamu Fueki
Working Group for the ICH S6 & Related Issues
Pharmaceuticals and Medical Devices Agency（ PMDA）

JOURNAL FREE ACCESS

2022 Volume 53 Issue 3 Pages 211-218

DOI https://doi.org/10.51018/pmdrs.53.3_211

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