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<p>A virtual bioequivalence (VBE) approach utilizing physiologically based pharmacokinetic (PBPK) modeling presents a compelling alternative for pharmaceutical industries. This method can significantly reduce the time and cost associated with clinical bioequivalence (BE) trials while minimizing the risk of detecting a type II error (a false negative), as well as a type I error (a false positive). Additionally, it aligns with ethical considerations by obviating the need to expose healthy volunteers to investigational drugs. To secure a biowaiver through the VBE approach, it is essential to translate compendial <i>in vitro</i> dissolution data into pharmacokinetic (PK) parameters using PBPK modeling to evaluate BE. This article reflects three concepts: compendial dissolution test, PBPK modeling, and BE, reviewing their historical development and current research. It highlights the gaps and challenges and discusses potential future opportunities to strengthen clear linkage among three concepts. A deeper understanding of the mechanisms and mathematical translation of dosage form disintegration and API particle dissolution can enhance the prediction of dosage form performance in both <i>in vivo</i> and <i>in vitro</i> settings. Future advancement of PBPK modeling should incorporate these developments to improve confidence in correlating compendial dissolution data with quantitative risk assessments of BE outcomes.</p> Graphical Abstract <p></p>

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Commentary and Review on Prospective Prediction of Bioequivalence of Oral Dosage Forms using Compendial Dissolution Testing and PBPK Modeling

  • 期刊论文

  • 发表日期：

    2025年9月3日

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  • Kazuko Sagawa,
  • Priyanka Thipsay

摘要

A virtual bioequivalence (VBE) approach utilizing physiologically based pharmacokinetic (PBPK) modeling presents a compelling alternative for pharmaceutical industries. This method can significantly reduce the time and cost associated with clinical bioequivalence (BE) trials while minimizing the risk of detecting a type II error (a false negative), as well as a type I error (a false positive). Additionally, it aligns with ethical considerations by obviating the need to expose healthy volunteers to investigational drugs. To secure a biowaiver through the VBE approach, it is essential to translate compendial in vitro dissolution data into pharmacokinetic (PK) parameters using PBPK modeling to evaluate BE. This article reflects three concepts: compendial dissolution test, PBPK modeling, and BE, reviewing their historical development and current research. It highlights the gaps and challenges and discusses potential future opportunities to strengthen clear linkage among three concepts. A deeper understanding of the mechanisms and mathematical translation of dosage form disintegration and API particle dissolution can enhance the prediction of dosage form performance in both in vivo and in vitro settings. Future advancement of PBPK modeling should incorporate these developments to improve confidence in correlating compendial dissolution data with quantitative risk assessments of BE outcomes.

Graphical Abstract