Lost in modelling and simulation?

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. (C) 2021 by the authors. This article is an open-access article distributed under the terms and conditions of the Creative Commons Attribution license(http://creativecommons.org/licenses/by/4.0/).

Automated summary

Physiologically-based pharmacokinetic modelling is considered a powerful tool for drug discovery and development, but recent studies show that the predictive power of current oral absorption models needs improvement. There is disagreement between industry and regulators regarding the credibility of PBPK modelling, leading to the establishment of new policies by editorial boards.