医薬品開発における母集団薬物動態および薬物動態／薬力学研究の現状について

DOI 被引用文献4件 参考文献18件
  • 中出 進
    小野薬品工業株式会社薬物動態研究所 九州大学大学院薬学研究院薬物動態学分野
  • 中西 美智
    小野薬品工業株式会社薬物動態研究所
  • 樋口 駿
    九州大学大学院薬学研究院薬物動態学分野

書誌事項

タイトル別名
  • Current Status of Population Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Studies in Drug Development
  • Pharmacodynamic Studies in Drug Development
  • 薬力学研究の現状について

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抄録

On the basis of the notice of the ICH-E5 guideline, it has become evident that the similarity between the characteristics in the relationship (PK/PD) of pharmacokinetics (PK) and efficacy or safety (PD) is the important factor for bridging to be established. Due to this, attention has been recently paid to population pharmacokinetics (PPK) and PK/PD. Hence, we have investigated the current research status in PPK and PK/PD in actual drug development processes and in relation to bridging. The subject of the investigation was the 137 NDA review data disclosed on internet from September of 1999 to March of 2003 by the Ministry of Welfare and Labor. In addition, in order to make a comparison with the domestic cases, we investigated 67 cases among the NDA review data of 2001 by the FDA. As a result of the investigation, the rates of implementation of PPK and PK/PD research in Japan were low, both around 5%. In foreign countries, that of PPK was 14.9% and that of PK/PD 38.8%, which were both higher than those of Japan. Among the 9 drugs, which had been approved in Japan by utilizing bridging studies, there was only one drug approved by use of PPK research, 4 drugs by PK/PD research, and one drug by PK/PD study that was established as a bridging study. These results emphasize that PPK and PK/PD research have not effectively functioned in drug developmen to date.

収録刊行物

  • 臨床薬理

    臨床薬理 34 (6), 329-338, 2003

    一般社団法人 日本臨床薬理学会

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