TY - JOUR
T1 - Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs
AU - Hayakawa, Yoshihiro
AU - Kawada, Manabu
AU - Nishikawa, Hiroyoshi
AU - Ochiya, Takahiro
AU - Saya, Hideyuki
AU - Seimiya, Hiroyuki
AU - Yao, Ryoji
AU - Hayashi, Masahiro
AU - Kai, Chieko
AU - Matsuda, Akira
AU - Naoe, Tomoki
AU - Ohtsu, Atsushi
AU - Okazaki, Taku
AU - Saji, Hideo
AU - Sata, Masataka
AU - Sugimura, Haruhiko
AU - Sugiyama, Yuichi
AU - Toi, Masakazu
AU - Irimura, Tatsuro
N1 - Publisher Copyright:
© 2016 Japanese Cancer Association.
PY - 2016/2/1
Y1 - 2016/2/1
N2 - 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.
AB - 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.
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U2 - 10.1111/cas.12857
DO - 10.1111/cas.12857
M3 - Article
C2 - 26919617
AN - SCOPUS:84959038257
VL - 107
SP - 189
EP - 202
JO - Cancer Science
JF - Cancer Science
SN - 1347-9032
IS - 2
ER -