Characteristics of Medical Products Comprising Human Cells, Genes, or Tissues Developed in Japan and the European Union Compared via Public Assessment Reports

por Kurauchi, Ryosuke, Kasai, Hiroi, Ito, Tatsuya
Publicado 2020

A descriptive research: Exclusion from submitted clinical data package in the review process of new drug approval due to GCP violation in Japan

por Asada, Ryuta, Yoshimura, Kenichi, Hattori, Kayo, Nonaka, Yujiro, Kasai, Hiroi, Shimizu, Shinobu
Publicado 2019

Preclinical Validation of Talaporfin Sodium-Mediated Photodynamic Therapy for Esophageal Squamous Cell Carcinoma

por Ohashi, Shinya, Kikuchi, Osamu, Tsurumaki, Mihoko, Nakai, Yukie, Kasai, Hiroi, Horimatsu, Takahiro, Miyamoto, Shin'ichi, Shimizu, Akira, Chiba, Tsutomu, Muto, Manabu
Publicado 2014

A multicenter phase II study of salvage photodynamic therapy using talaporfin sodium (ME2906) and a diode laser (PNL6405EPG) for local failure after chemoradiotherapy or radiothera...

por Yano, Tomonori, Kasai, Hiroi, Horimatsu, Takahiro, Yoshimura, Kenichi, Teramukai, Satoshi, Morita, Satoshi, Tada, Harue, Yamamoto, Yoshinobu, Kataoka, Hiromi, Kakushima, Naomi, Ishihara, Ryu, Isomoto, Hajime, Muto, Manabu
Publicado 2016

Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation

por Nakamura, Kenichi, Ozawa, Hitoshi, Shibata, Taro, Ushirozawa, Nobuko, Hata, Tomomi, Okita, Natsuko, Fuse, Nozomu, Sato, Norihiro, Ikeda, Koji, Hanaoka, Hideki, Maruyama, Tatsuya, Wada, Michihiko, Shimizu, Shinobu, Kasai, Hiroi, Yamamoto, Yoichi, Sakurai, Jun, Todaka, Koji, Tashiro, Shimon, Yamamoto, Haruko
Publicado 2021

A randomized, 3-arm, neoadjuvant, phase 2 study comparing docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP), TCbHP followed by trastuzumab emtansine and pertuzumab (T-DM1+...

por Masuda, Norikazu, Ohtani, Shoichiro, Takano, Toshimi, Inoue, Kenichi, Suzuki, Eiji, Nakamura, Rikiya, Bando, Hiroko, Ito, Yoshinori, Ishida, Kazushige, Yamanaka, Takashi, Kuroi, Katsumasa, Yasojima, Hiroyuki, Kasai, Hiroi, Takasuka, Tsuyoshi, Sakurai, Takaki, Kataoka, Tatsuki R., Morita, Satoshi, Ohno, Shinji, Toi, Masakazu
Publicado 2020

Eribulin-based neoadjuvant chemotherapy for triple-negative breast cancer patients stratified by homologous recombination deficiency status: a multicenter randomized phase II clini...

por Masuda, Norikazu, Bando, Hiroko, Yamanaka, Takashi, Kadoya, Takayuki, Takahashi, Masato, Nagai, Shigenori E., Ohtani, Shoichiro, Aruga, Tomoyuki, Suzuki, Eiji, Kikawa, Yuichiro, Yasojima, Hiroyuki, Kasai, Hiroi, Ishiguro, Hiroshi, Kawabata, Hidetaka, Morita, Satoshi, Haga, Hironori, Kataoka, Tatsuki R., Uozumi, Ryuji, Ohno, Shinji, Toi, Masakazu
Publicado 2021