抗癌药物非临床安全性评价需考虑的要点。

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

作者信息

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

机构信息

Tokyo Metropolitan Institute of Public Health, Tokyo, Japan.

出版信息

J Toxicol Sci. 2008 May;33(2):123-6. doi: 10.2131/jts.33.123.

DOI:10.2131/jts.33.123

PMID:18544904

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.

摘要

由于恶性肿瘤危及生命，这些疾病的死亡率很高，且现有治疗方法效果有限，因此希望能尽快为肿瘤患者提供新的有效抗癌药物。然而，对于首次人体临床试验及日本批准申请所需的抗癌药物研发非临床安全性研究，尚无相关指南。于是，厚生劳动省（MHLW）于2004年成立了由监管、学术和产业科学家组成的协作小组，以制定抗癌药物非临床安全性评估指南。作为抗癌药物非临床安全性研究基本概念的指南，该小组于2007年编写了“要点考虑”文件。