title: Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan.
authors.affiliation: Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo, Japan. uyama-yoshiaki@pmda.go.jp
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Uyama
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.forename: Naomi
authors.initials: N
authors.lastname: Nagai
authors.forename: Hideki
authors.initials: H
authors.lastname: Hanaoka
authors.forename: Satoshi
authors.initials: S
authors.lastname: Toyoshima
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Mori
mesh_terms: 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