新薬開発の薬物動態研究における最近の動向 Recent Trend of Pharmacokinetic Studies in New Drug Development

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著者

    • 岩崎 一秀 IWASAKI Kazuhide
    • (株)新日本科学 コントラクト事業カンパニー 営業統括本部 Business Development Department, Contract Research Company, Shin Nippon Biomedical Laboratories, Ltd.

抄録

Although the expenditure for new drug development by the pharmaceutical industry has been increasing in recent years, the number of new drugs approved has remained unchanged or has been gradually decreasing. For the effective development of new drugs, attrition rates of drug candidates should be reduced. In 1991, major causes of the attrition were ADME (absorption, distribution, metabolism and excretion) (about 40%), efficacy (about 30%), and safety issues (about 25%). In 2000, the causes were ADME (less than 10%), efficacy (about 30%), and safety issues (about 30%). Between 1991 and 2000, the attrition caused by ADME issues decreased drastically, but that caused by efficacy and safety issues did not change. To improve this situation, exploratory clinical studies including microdose and exploratory IND (Investigational New Drug) studies proposed in EU and USA, respectively, have been started at the late 1990s and the early 2000s. This commentary reviews the current situation of the exploratory clinical studies and the recent trend of pharmacokinetic studies in new drug development.

収録刊行物

  • 質量分析 = Mass spectroscopy  

    質量分析 = Mass spectroscopy 56(3), 139-142, 2008-06-01 

    The Mass Spectrometry Society of Japan

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各種コード

  • NII論文ID(NAID)
    10021086911
  • NII書誌ID(NCID)
    AN0010555X
  • 本文言語コード
    JPN
  • 資料種別
    REV
  • ISSN
    13408097
  • NDL 記事登録ID
    9541358
  • NDL 雑誌分類
    ZP4(科学技術--化学・化学工業--分析化学)
  • NDL 請求記号
    Z17-213
  • データ提供元
    CJP書誌  NDL  J-STAGE 
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