<b>Summary Report of Questionnaire Survey on Current Situation and Issues of Human Mass Balance Study Using Radioisotopes in Japan</b>

DOI Web Site 4 References
  • HASEGAWA Hiroshi
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • FURUTA Shigeru
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • KURIBAYASHI Shunji
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • TSUDA Minoru
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • SATSUKAWA Masahiro
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • SUZUKI Motohiro
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • ISHII Satoru
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • KONDO Hiroshi
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • MINATO Kouichi
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • SATO Takashi
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • TSUTSUI Masaru
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • KURAHASHI Yoshikazu
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • MIURA Shin-ichi
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • NAKAMURA Kazuichi
    Non-Clinical Evaluation Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)

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  • <b>本邦における放射性同位元素を使用したヒトマスバランス試験の現状と課題点に関するアンケート調査結果報告</b>

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A questionnaire on conventional “human mass balance (MB) study” was sent to 61 pharmaceutical companies affiliated with the Japan Pharmaceutical Manufacturers Association in 2013, and 48 companies responded. The strategy and design of MB study were also investigated with respect to the approved new molecular entities in Japan and the US from 2002 to 2013. Most companies conduct MB study during proof-of-concept clinical trials or before phase III studies. Additionally, FDA and ICH guidance have encouraged the companies to perform MB studies routinely and/or in an earlier phase. The present survey suggests that MB study has occupied an important position in new drug development, and that implementation of the study appears to be judged carefully taking the necessity into consideration.

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