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Title: Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs
Authors: Hayakawa, Yoshihiro
Kawada, Manabu
Nishikawa, Hiroyoshi
Ochiya, Takahiro
Saya, Hideyuki
Seimiya, Hiroyuki
Yao, Ryoji
Hayashi, Masahiro
Kai, Chieko
Matsuda, Akira
Naoe, Tomoki
Ohtsu, Atsushi
Okazaki, Taku
Saji, Hideo
Sata, Masataka
Sugimura, Haruhiko
Sugiyama, Yuichi
Toi, Masakazu
Irimura, Tatsuro
Author's alias: 佐治, 英郎
戸井, 雅和
Keywords: Animal model
drug development
oncology drug
regulatory science
Issue Date: Feb-2016
Publisher: Wiley-Blackwell
Journal title: Cancer Science
Volume: 107
Issue: 2
Start page: 189
End page: 202
Abstract: Non-clinical studies are necessary at each stage of the development of oncology drugs. Many experimental cancer models have been developed to investigate carcinogenesis, cancer progression, metastasis, and other aspects in cancer biology and these models turned out to be useful in the efficacy evaluation and the safety prediction of oncology drugs. While the diversity and the degree of engagement in genetic changes in the initiation of cancer cell growth and progression are widely accepted, it has become increasingly clear that the roles of host cells, tissue microenvironment, and the immune system also play important roles in cancer. Therefore, the methods used to develop oncology drugs should continuously be revised based on the advances in our understanding of cancer. In this review, we extensively summarize the effective use of those models, their advantages and disadvantages, ranges to be evaluated and limitations of the models currently used for the development and for the evaluation of oncology drugs.
Rights: © 2016 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
DOI(Published Version): 10.1111/cas.12857
Appears in Collections:Journal Articles

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