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Qualitative analysis of actual Standard for Exchange of Nonclinical Data (SEND) datasets for Data Domains: Proposition from Japan Pharmaceutical Manufacturers Association SEND Taskforce Team on standardization of nonclinical data.
Sato, Gen; Matsumoto, Izumi; Watanabe, Mayumi; Kinomoto, Toshiko; Nakajima, Mikio; Yamamoto, Masakatsu; Inoue, Yuki; Kobayashi, Keita; Tanaharu, Takashi; Kiya, Akinori; Yamaguchi, Takafumi; Hayashi, Hitomi; Motoyama, Keiko; Suzuki, Mutsumi; Watanabe, Kazuto.
Afiliação
  • Sato G; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Eisai Co., Ltd., 5-1-3 Tokodai, Tsukuba-shi, Ibaraki, 300-2635, Japan. Electronic address: g-sato@hhc.eisai.co.jp.
  • Matsumoto I; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Sumitomo Dainippon Pharma Co., Ltd., 3-1-98 Kasugade-naka, Konohana-ku, Osaka, 554-0022, Japan.
  • Watanabe M; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Daiichi Sankyo Co., Ltd., 1-16-13, Kitakasai, Edogawa-ku, Tokyo, 134-8630, Japan.
  • Kinomoto T; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; ZERIA Pharmaceutical Co., Ltd., 2512-1, Numagami, Oshikiri, Kumagaya-shi, Saitama, 360-0111, Japan.
  • Nakajima M; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Asahi Kasei Pharma Corporation, 632-1 Mifuku Izunokuni-shi, Shizuoka, 410-2321, Japan.
  • Yamamoto M; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; MSD K.K., Urban Ace Kitahama Bldg. 2-3-7 Hiranomachi, Chuo-ku, Osaka-city, Osaka, 541-0046, Japan.
  • Inoue Y; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Otsuka Pharmaceutical Co., Ltd., 463-10 Kagasuno, Kawauchi-cho, Tokushima, 771-0192, Japan.
  • Kobayashi K; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Kowa Company, Ltd., 332-1, OhnoShinden, Fuji-city, Shizuoka, 417-8650, Japan.
  • Tanaharu T; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Bristol-Myers Squibb K.K., Shinjuku i-Land Tower, 5-1, Nishi-Shinjuku 6-chome, Shinjuku-ku, Tokyo, 163-1327, Japan.
  • Kiya A; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Shionogi & Co., Ltd., 3-1-1, Futaba-Cho, Toyonaka, Osaka, 561-0825, Japan.
  • Yamaguchi T; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Eli Lilly Japan K.K., LILLY PLAZA ONE Bldg., 5-1-28, Isogamidori, Chuo-ku, Kobe, 651-0086, Japan.
  • Hayashi H; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Nippon Kayaku Co., Ltd., 31-12, Shimo 3-chome, Kita-ku, Tokyo, 115-0042, Japan.
  • Motoyama K; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Janssen Pharmaceutical K.K., 3-5-2 Nishi-kanda, Chiyoda-ku, Tokyo, 101-0065, Japan.
  • Suzuki M; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Kyowa Kirin Co., Ltd., 1188, Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8731, Japan.
  • Watanabe K; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Chugai Pharmaceutical Co., Ltd., 1-135 Komakado, Gotemba, Shizuoka, 412-8513, Japan.
Regul Toxicol Pharmacol ; 122: 104919, 2021 Jun.
Article em En | MEDLINE | ID: mdl-33753112
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Bases de Dados como Assunto / Pesquisa Biomédica / Indústria Farmacêutica Idioma: En Ano de publicação: 2021 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Bases de Dados como Assunto / Pesquisa Biomédica / Indústria Farmacêutica Idioma: En Ano de publicação: 2021 Tipo de documento: Article