Points to consider on the non-clinical safety evaluation of anticancer drugs

Dai Nakae; Horoshi Onodera; Osamu Fueki; Tsutomu Urano; Noriyuki Komiyama; Fumio Sagami; Shuichi Kai; Chihiro Nishimura; Tohru Inoue

doi:10.2131/jts.33.123

Review

Points to consider on the non-clinical safety evaluation of anticancer drugs

Dai Nakae, Horoshi Onodera, Osamu Fueki, Tsutomu Urano, Noriyuki Komiyama, Fumio Sagami, Shuichi Kai, Chihiro Nishimura, Tohru Inoue

Author information

Dai Nakae
Tokyo Metropolitan Institute of Public Health
Horoshi Onodera
Pharmaceuticals and Medical Devices Agency
Osamu Fueki
Pharmaceuticals and Medical Devices Agency
Tsutomu Urano
Pharmaceuticals and Medical Devices Agency
Noriyuki Komiyama
Pharmaceuticals and Medical Devices Agency
Fumio Sagami
Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
Eisai Co., Ltd.
Shuichi Kai
Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
Bristol-Myers K.K.
Chihiro Nishimura
Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
Nippon Kayaku Co., Ltd.
Tohru Inoue
Biological Safety Research Center, National Institute of Health Sciences

Keywords: Points to consider, Non-clinical safety evaluation, Anticancer drugs, First in human clinical trial, Approval application

JOURNAL FREE ACCESS
Supplementary material

2008 Volume 33 Issue 2 Pages 123-126

DOI https://doi.org/10.2131/jts.33.123

Details

Abstract

Since malignant tumors are life-threatening, the death rate from these diseases is high, and existing therapies have limited effectiveness, it is desired to provide new effective anticancer drugs to tumor patients sooner. However, there is no guideline regarding non-clinical safety studies on the development of anticancer drugs required for the first in human clinical trials and for the approval applications in Japan. Then, the Ministry of Health, Labour and Welfare (MHLW) established the collaboration group including regulatory, academic and industrial scientists to prepare the guideline on the non-clinical safety evaluation of anticancer drugs in 2004. As a guide for basic concept of non-clinical safety studies on anticancer drugs, the "Points to Consider" document was prepared by this group in 2007.

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