Model-Based Drug Developmentの基礎および実例紹介

DOI Web Site Web Site 参考文献16件
  • 長谷川 千尋
    小野薬品工業株式会社トランスレーショナルメディシンセンタークリニカルファーマコロジー部
  • 佐々木 智啓
    日本ベーリンガーインゲルハイム株式会社医薬開発本部臨床薬物動態部

書誌事項

タイトル別名
  • Model-Based Drug Development: Basics and Its Application
  • Model-Based Drug Development ノ キソ オヨビ ジツレイ ショウカイ

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説明

In drug development, the low productivity causing escalated costs has been documented for over the past decade. To overcome this significant challenge, Model-Based Drug Development (MBDD) is considered as one of the opportunities. MBDD is the drug development based on the integrated pharmaco-statistical models of drug efficacy and safety with available data and their application to inform development strategy, trial design and decision-making in the drug development. MBDD covers overall drug development stage including both pre-clinical and clinical stage and improves knowledge management and decision-making in a quantitative manner. This article introduces basics of MBDD from the theoretical and the practical point of view with some examples and shows its application for the clinical drug development of the anti-diabetes drug.

収録刊行物

  • 計量生物学

    計量生物学 36 (Special_Issue), S65-S84, 2015

    日本計量生物学会

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