The Journal of Toxicological Sciences
Online ISSN : 1880-3989
Print ISSN : 0388-1350
ISSN-L : 0388-1350
Review
Points to consider on the non-clinical safety evaluation of anticancer drugs
Dai NakaeHoroshi OnoderaOsamu FuekiTsutomu UranoNoriyuki KomiyamaFumio SagamiShuichi KaiChihiro NishimuraTohru Inoue
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JOURNALS FREE ACCESS

2008 Volume 33 Issue 2 Pages 123-126

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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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© 2008 The Japanese Society of Toxicology
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