コンペンディアル溶解試験とPBPKモデリングを用いた口服用用薬剤の将来性予測に関する解説とレビュー

Kazuko Sagawa1, Priyanka Thipsay2

  • 1Pharmaceutical Science, Pfizer Worldwide Research and Development, 445 Eastern Point Road, Groton, Connecticut, 06340, USA. kazuko.sagawa@pfizer.com.

The AAPS journal
|September 3, 2025
PubMed
まとめ

生理学的な薬動力学 (PBPK) モデリングを用いた仮想生物同等性 (VBE) は,臨床試験のより速く,より安く,より倫理的な代替案を提供します. このアプローチは, in vitro 溶解データと 薬動学的パラメータを結びつけ, 堅固な生物同等性評価を行うことができます.

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