Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan.
Uyama
Yoshiaki
Y
Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo, Japan. uyama-yoshiaki@pmda.go.jp
Shibata
Taro
T
Nagai
Naomi
N
Hanaoka
Hideki
H
Toyoshima
Satoshi
S
Mori
Kazuhiko
K
D002986:Clinical Trials as Topic / Q000592:standards* / Q000639:trends; D017277:Drug Approval; D017408:Guidelines as Topic; D006801:Humans; D017387:Investigational New Drug Application; D007564:Japan