Lost in Modelling and Simulation?

Overview

Journal ADMET DMPK

Specialty Pharmacology

Date 2022 Mar 18

PMID 35299768

Authors

Kiyohiko Sugano

Affiliations

Soon will be listed here.

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.

Citing Articles

Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.

Pepin X, Arora S, Borges L, Cano-Vega M, Carducci T, Chatterjee P Mol Pharm. 2024; 21(8):3697-3731.

PMID: 38946085 PMC: 11304397. DOI: 10.1021/acs.molpharmaceut.4c00526.

Model-Informed Drug Development: In Silico Assessment of Drug Bioperformance following Oral and Percutaneous Administration.

Djuris J, Cvijic S, Djekic L Pharmaceuticals (Basel). 2024; 17(2).

PMID: 38399392 PMC: 10892858. DOI: 10.3390/ph17020177.

Food and bile micelle binding of quaternary ammonium compounds.

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Reyes-Aldasoro C Cancers (Basel). 2023; 15(15).

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Modelling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies.

Karnati P, Murthy A, Gundeti M, Ahmed T AAPS J. 2023; 25(4):63.

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