Japanese regulation of biosimilar products: past experience and current challenges von Arato, Teruyo

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Implementation status of pharmacological studies in the development of orphan drugs von Yokoshiki, Saki, Arato, Teruyo

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Exploring Factors Affecting the Acceptance of Genetically Edited Food Among Youth in Japan von Farid, Mohamed, Cao, Jianfei, Lim, Yeongjoo, Arato, Teruyo, Kodama, Kota

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Challenges for Streamlining the Development of Biosimilars: A Japanese Perspective von Arato, Teruyo

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Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugs von Maeda, Kojiro, Kaneko, Masayuki, Narukawa, Mamoru, Arato, Teruyo

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Research on advanced intervention using novel bone marrOW stem cell (RAINBOW): a study protocol for a phase I, open-label, uncontrolled, dose-response trial of autologous bone marr... von Shichinohe, Hideo, Kawabori, Masahito, Iijima, Hiroaki, Teramoto, Tuyoshi, Abumiya, Takeo, Nakayama, Naoki, Kazumata, Ken, Terasaka, Shunsuke, Arato, Teruyo, Houkin, Kiyohiro

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Cell and gene therapy approvals in Japan and the need for international harmonization von Arato, Teruyo, Nomura, Kaori

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Protocol for treating lumbar spinal canal stenosis with a combination of ultrapurified, allogenic bone marrow-derived mesenchymal stem cells and in situ-forming gel: a multicentre,... von Sudo, Hideki, Miyakoshi, Takashi, Watanabe, Yudai, Ito, Yoichi M, Kahata, Kaoru, Tha, Khin Khin, Yokota, Nozomi, Kato, Hiroe, Terada, Tomoko, Iwasaki, Norimasa, Arato, Teruyo, Sato, Norihiro, Isoe, Toshiyuki

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Quality, safety and efficacy of follow-on biologics in Japan von Yamaguchi, Teruhide, Arato, Teruyo

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Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation: Study protocol for a first-in-human pilot study von Yamada, Katsuhisa, Kenichiro, Maeda, Ito, Yoichi M., Inage, Fujio, Isoe, Toshiyuki, Yokota, Nozomi, Sugita, Osamu, Sato, Norihiro, Tha, Khin Khin, Iwasaki, Norimasa, Arato, Teruyo, Sudo, Hideki

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Comparative Study of Functional Food Regulations in Japan and Globally von Farid, Mohamed, Kodama, Kota, Arato, Teruyo, Okazaki, Takashi, Oda, Tetsuaki, Ikeda, Hideko, Sengoku, Shintaro

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2015 Guidance on cancer immunotherapy development in early‐phase clinical studies von Arato, Teruyo, Daimon, Takashi, Heike, Yuji, Ishii, Ken, Itho, Kyogo, Kageyama, Shinichi, Kawakami, Yutaka, Nakayama, Eiichi, Ozawa, Keiya, Sato, Noriyuki, Shiku, Hiroshi, Takeuchi, Masahiro, Tani, Kenzaburo, Tamada, Koji, Ueda, Ryuzo, Yamaguchi, Yoshiyuki, Yamanaka, Takeharu, Yamaue, Hiroki, Yasukawa, Masaki, Iguchi, Toyotaka, Kitano, Shigehisa, Miyahara, Yoshihiro, Nagata, Yasuhiro, Noguchi, Masanori, Terashima, Takeshi, Asano, Takeo, Asonuma, Motohiro, Ikeda, Hiroaki, Kakimi, Kazuhiro, Takesako, Kazutoh, Tanaka, Masanori, Amakasu, Kohei, Yamada, Akira, Harada, Naozumi, Aoshi, Taiki, Kuroda, Etsushi, Kobiyama, Kouji, Muraoka, Daisuke, Yamazaki, Naoya, Kuchiba, Aya, Tanaka, Shiro, Michimae, Hirofumi, Yamada, Tomomi, Hanada, Kenichi, Okada, Hideho, Takebe, Naoko, Hirano, Naoto, Okumura, Satoshi, Sato, Daisaku, Shibatsuji, Masayoshi, Yamaguchi, Teruhide

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A comparative study of monosaccharide composition analysis as a carbohydrate test for biopharmaceuticals von Harazono, Akira, Kobayashi, Tetsu, Kawasaki, Nana, Itoh, Satsuki, Tada, Minoru, Hashii, Noritaka, Ishii, Akiko, Arato, Teruyo, Yanagihara, Shigehiro, Yagi, Yuki, Koga, Akiko, Tsuda, Yuriko, Kimura, Mikiko, Sakita, Masashi, Kitamura, Satoshi, Yamaguchi, Hideto, Mimura, Hisashi, Murata, Yoshimi, Hamazume, Yasuki, Sato, Takayuki, Natsuka, Shunji, Kakehi, Kazuaki, Kinoshita, Mitsuhiro, Watanabe, Sakie, Yamaguchi, Teruhide

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Considerations of the Japanese Research Working Group for the ICH S6 & Related Issues Regarding Nonclinical Safety Assessments of Oligonucleotide Therapeutics: Comparison with Thos... von Hirabayashi, Yoko, Maki, Kazushige, Kinoshita, Kiyoshi, Nakazawa, Takahiro, Obika, Satoshi, Naota, Misaki, Watanabe, Kazuto, Suzuki, Mutsumi, Arato, Teruyo, Fujisaka, Aki, Fueki, Osamu, Ito, Kosuke, Onodera, Hiroshi

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Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan von Arato, Teruyo, Yamaguchi, Teruhide

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Accelerating Cell Therapy for Stroke in Japan: Regulatory Framework and Guidelines on Development of Cell-Based Products von Houkin, Kiyohiro, Shichinohe, Hideo, Abe, Koji, Arato, Teruyo, Dezawa, Mari, Honmou, Osamu, Horie, Nobutaka, Katayama, Yasuo, Kudo, Kohsuke, Kuroda, Satoshi, Matsuyama, Tomohiro, Miyai, Ichiro, Nagata, Izumi, Niizuma, Kuniyasu, Sakushima, Ken, Sasaki, Masanori, Sato, Norihiro, Sawanobori, Kenji, Suda, Satoshi, Taguchi, Akihiko, Tominaga, Teiji, Yamamoto, Haruko, Yamashita, Toru, Yoshimine, Toshiki

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Over‐expression of cyclin D1 induces glioma invasion by increasing matrix metalloproteinase activity and cell motility von Arato‐Ohshima, Teruyo, Sawa, Hiroki

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Mechanism Responsible for Oligomycin-induced Occlusion of Na+ within Na/K-ATPase von Teruyo, Arato-Oshima, Matsui, Hideo, Wakizaka, Akira, Homareda, Haruo

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Industry-government — academia cooperation center for medical innovation in Hokkaido University von Kodama, Kota B, Arato, Teruyo

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Reduction in Blood Free Carnitine Levels in Association with Changes in Sodium Valproate (VPA) Disposition in Epileptic Patients Treated with VPA and Other Anti-epileptic Drugs von HIRAOKA, Atsushi, ARATO, Teruyo, TOMINAGA, Itaru

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