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タイトル: | Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs |
著者: | 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 https://orcid.org/0000-0003-1488-9958 (unconfirmed) Irimura, Tatsuro |
著者名の別形: | 佐治, 英郎 戸井, 雅和 |
キーワード: | Animal model cancer drug development oncology drug regulatory science |
発行日: | Feb-2016 |
出版者: | Wiley-Blackwell |
誌名: | Cancer Science |
巻: | 107 |
号: | 2 |
開始ページ: | 189 |
終了ページ: | 202 |
抄録: | 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. |
著作権等: | © 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. |
URI: | http://hdl.handle.net/2433/226668 |
DOI(出版社版): | 10.1111/cas.12857 |
PubMed ID: | 26919617 |
出現コレクション: | 学術雑誌掲載論文等 |
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