Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs

Yoshihiro Hayakawa, Manabu Kawada, Hiroyoshi Nishikawa, Takahiro Ochiya, Hideyuki Saya, Hiroyuki Seimiya, Ryoji Yao, Masahiro Hayashi, Chieko Kai, Akira Matsuda, Tomoki Naoe, Atsushi Ohtsu, Taku Okazaki, Hideo Saji, Masataka Sata, Haruhiko Sugimura, Yuichi Sugiyama, Masakazu Toi, Tatsuro Irimura

研究成果: Article査読

1 被引用数 (Scopus)

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. This review summarizes the effective use of animal 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.

本文言語English
ページ(範囲)189-202
ページ数14
ジャーナルCancer science
107
2
DOI
出版ステータスPublished - 2016 2月 1

ASJC Scopus subject areas

  • 腫瘍学
  • 癌研究

フィンガープリント

「Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs」の研究トピックを掘り下げます。これらがまとまってユニークなフィンガープリントを構成します。

引用スタイル