The Contribution of GMP-grade Hospital Preparation to Translational Research

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  • Yonezawa Atsushi
    Department of Clinical Pharmacology & Therapeutics, Kyoto University Hospital
  • Kajiwara Moto
    Department of Clinical Pharmacology & Therapeutics, Kyoto University Hospital
  • Minami Ikuko
    Department of Clinical Pharmacology & Therapeutics, Kyoto University Hospital
  • Omura Tomohiro
    Department of Clinical Pharmacology & Therapeutics, Kyoto University Hospital
  • Nakagawa Shunsaku
    Department of Clinical Pharmacology & Therapeutics, Kyoto University Hospital
  • Matsubara Kazuo
    Department of Clinical Pharmacology & Therapeutics, Kyoto University Hospital

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Other Title
  • 治験薬GMP基準の院内製剤製造によるトランスレーショナルリサーチへの貢献
  • Symposium Review 治験薬GMP基準の院内製剤製造によるトランスレーショナルリサーチへの貢献
  • Symposium Review チケンヤク GMP キジュン ノ インナイ セイザイ セイゾウ ニ ヨル トランスレーショナルリサーチ エ ノ コウケン

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Abstract

  Translational research is important for applying the outcomes of basic research studies to practical medical treatments. In exploratory early-phase clinical trials for an innovative therapy, researchers should generally manufacture investigational agents by themselves. To provide investigational agents with safety and high quality in clinical studies, appropriate production management and quality control are essential. In the Department of Pharmacy of Kyoto University Hospital, a manufacturing facility for sterile drugs was established, independent of existing manufacturing facilities. Manuals on production management and quality control were developed according to Good Manufacturing Practices (GMP) for Investigational New Drugs (INDs). Advanced clinical research has been carried out using investigational agents manufactured in our facility. These achievements contribute to both the safety of patients and the reliability of clinical studies. In addition, we are able to do licensing-out of our technique for the manufacture of investigational drugs. In this symposium, we will introduce our GMP grade manufacturing facility for sterile drugs and discuss the role of GMP grade hospital preparation in translational research.<br>

Journal

  • YAKUGAKU ZASSHI

    YAKUGAKU ZASSHI 135 (8), 943-947, 2015-08-01

    The Pharmaceutical Society of Japan

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