Sugano Kiyohiko
Molecular Pharmaceutics Lab., College of Pharmaceutical Sciences, Ritsumeikan University, 1-1-1, Noji-higashi, Kusatsu, Shiga 525-8577, Japan.
ADMET DMPK. 2021 Mar 22;9(2):75-109. doi: 10.5599/admet.923. eCollection 2021.
Over the past few decades, physiologically-based pharmacokinetic modelling (PBPK) has been anticipated to be a powerful tool to improve the productivity of drug discovery and development. However, recently, multiple systematic evaluation studies independently suggested that the predictive power of current oral absorption (OA) PBPK models needs significant improvement. There is some disagreement between the industry and regulators about the credibility of OA PBPK modelling. Recently, the editorial board of AMDET&DMPK has announced the policy for the articles related to PBPK modelling (Modelling and simulation ethics). In this feature article, the background of this policy is explained: (1) Requirements for scientific writing of PBPK modelling, (2) Scientific literacy for PBPK modelling, and (3) Middle-out approaches. PBPK models are a useful tool if used correctly. This article will hopefully help advance the science of OA PBPK models.
在过去几十年里，基于生理的药代动力学建模（PBPK）一直被视为提高药物研发效率的有力工具。然而，最近多项独立的系统评估研究表明，当前口服吸收（OA）PBPK模型的预测能力需要显著提高。在行业和监管机构之间，对于OA PBPK建模的可信度存在一些分歧。最近，《药物代谢与处置和药物代谢与药代动力学》（AMDET&DMPK）编辑委员会宣布了与PBPK建模相关文章的政策（建模与模拟伦理）。在这篇专题文章中，将解释该政策的背景：（1）PBPK建模的科学写作要求，（2）PBPK建模的科学素养，以及（3）由中间向外的方法。如果使用得当，PBPK模型是一个有用的工具。本文有望推动OA PBPK模型科学的发展。
