Open AccessReport on the use of non‐clinical studies in the regulatory evaluation of oncology drugs
Author(s) -
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
Publication year - 2016
Publication title -
cancer science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 141
eISSN - 1349-7006
pISSN - 1347-9032
DOI - 10.1111/cas.12857
Subject(s) - cancer , medicine , clinical oncology , tumor microenvironment , carcinogenesis , oncology , drug development , bioinformatics , metastasis , biology , pharmacology , drug
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.