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A Modeling and Simulation Method for Preliminary Design of an Electro-Variable Displacement Pump
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Lost in modelling and simulation?

Kiyohiko Sugano1

  • 1Molecular Pharmaceutics Lab., College of Pharmaceutical Sciences, Ritsumeikan University, 1-1-1, Noji-higashi, Kusatsu, Shiga 525-8577, Japan.

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|March 18, 2022
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Summary

Physiologically-based pharmacokinetic (PBPK) models show promise in drug discovery but require improved predictive power for oral absorption (OA). This article clarifies PBPK modelling ethics and best practices for advancing OA PBPK science.

Keywords:
middle-out approachphysiologically-based pharmacokinetic modellingreproducibilityscientific literacystructural identifiabilitytransparency

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Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Computational Biology and Bioinformatics

Background:

  • Physiologically-based pharmacokinetic (PBPK) modeling has long been recognized for its potential to enhance drug discovery and development efficiency.
  • Recent systematic evaluations indicate a need for substantial improvements in the predictive accuracy of current oral absorption (OA) PBPK models.
  • Discrepancies exist between industry expectations and regulatory perspectives regarding the reliability of OA PBPK modeling.

Purpose of the Study:

  • To explain the background and rationale behind the new policy on PBPK modeling articles announced by the editorial board of AMDET&DMPK.
  • To outline requirements for scientific writing in PBPK modeling.
  • To promote scientific literacy and introduce middle-out approaches in PBPK modeling.

Main Methods:

  • Discussion of scientific writing requirements for PBPK models.
  • Exploration of scientific literacy essential for PBPK modeling.
  • Introduction of middle-out approaches as a methodological strategy.

Main Results:

  • The article clarifies the ethical considerations and scientific standards for PBPK modeling publications.
  • It highlights the importance of proper application and understanding of PBPK models.
  • It aims to guide researchers in improving the scientific rigor of OA PBPK models.

Conclusions:

  • PBPK models are valuable tools when applied correctly, emphasizing the need for adherence to scientific standards.
  • The discussed policy and approaches aim to enhance the credibility and utility of OA PBPK models in drug development.
  • Advancing the science of OA PBPK models requires a focus on scientific literacy, ethical writing, and appropriate methodologies.