Points to consider on the non-clinical safety evaluation ofanticancer drugs

摘要

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 drags 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 drags in 2004. As a guide for basic concept of non-clinical safety studies on anticancer drags, the "Points to Consider" document was prepared by this group in 2007.