ADMET and DMPK, Vol. 9 No. 2, 2021.
Review article
https://doi.org/10.5599/admet.923
Lost in modelling and simulation?
Kiyohiko Sugano
; Molecular Pharmaceutics Lab., College of Pharmaceutical Sciences, Ritsumeikan University, 1-1-1, Noji-higashi, Kusatsu, Shiga 525-8577, Japan
Abstract
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.
Keywords
physiologically-based pharmacokinetic modelling; scientific literacy; transparency; reproducibility; middle-out approach; structural identifiability
Hrčak ID:
254181
URI
Publication date:
21.3.2021.
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