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Interlaboratory comparison about feasibility of insoluble particulate matter test for injections with reduced test volume in light obscuration method.
Harazono, Akira; Shibata, Hiroko; Kiyoshi, Masato; Muto, Takashi; Fukuda, Jun; Torisu, Tetsuo; Saitoh, Satoshi; Nishimura, Hirotaka; Uchiyama, Susumu; Ishii-Watabe, Akiko.
Affiliation
  • Harazono A; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tonomachi 3-25-26, Kawasaki-ku, Kanagawa, 210-9501, Japan. Electronic address: harazono@nihs.go.jp.
  • Shibata H; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tonomachi 3-25-26, Kawasaki-ku, Kanagawa, 210-9501, Japan.
  • Kiyoshi M; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tonomachi 3-25-26, Kawasaki-ku, Kanagawa, 210-9501, Japan.
  • Muto T; Biotechnology Labs., Pharmaceutical Technology, Astellas Pharma Inc., 5-2-3, Tokodai, Tsukuba-shi, Ibaraki, 300-2698, Japan.
  • Fukuda J; Product Strategy Group, Corporate Strategy and Planning Department, Kyowa Hakko Kirin Co., Ltd, Otemachi Financial City Grand Cube, 1-9-2, Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan.
  • Torisu T; Product Operations, Global Vaccine Business Unit, Takeda Pharmaceutical Company Limited, 4720, Takeda, Mitsui, Hikari, Yamaguchi, 743-0011, Japan.
  • Saitoh S; Quality Development Dept., Pharmaceutical Technology Div., Chugai Pharma Manufacturing Co., Ltd., 5-1, Ukima, 5-chome, Kita-ku, Tokyo, 115-8543, Japan.
  • Nishimura H; Pharmaceutical Laboratory, Mochida Pharmaceutical Co., Ltd, 342 Gensuke, Fujieda, Shizuoka, 426-8640, Japan.
  • Uchiyama S; U-Medico Inc., 2-1 Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka, 565-0871, Japan.
  • Ishii-Watabe A; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tonomachi 3-25-26, Kawasaki-ku, Kanagawa, 210-9501, Japan.
Biologicals ; 57: 46-49, 2019 Jan.
Article in En | MEDLINE | ID: mdl-30553568
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Chemistry Techniques, Analytical / Feasibility Studies / Drug Contamination / Particulate Matter Type of study: Guideline Limits: Animals / Humans Language: En Journal: Biologicals Journal subject: ALERGIA E IMUNOLOGIA Year: 2019 Type: Article
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Chemistry Techniques, Analytical / Feasibility Studies / Drug Contamination / Particulate Matter Type of study: Guideline Limits: Animals / Humans Language: En Journal: Biologicals Journal subject: ALERGIA E IMUNOLOGIA Year: 2019 Type: Article