Physiologically based pharmacokinetic (PBPK) modelling of oral drug absorption in older adults – an AGePOP review

DeMeester, Cynthia A.; Robins, David J.; Edwina, Angela Elma; Tournoy, Jos; Augustijns, Patrick; Ince, Ibrahim; Lehmann, Andreas; Vertzoni, Maria; Schlender, Jan

doi:10.1016/j.ejps.2023.106496

Cited by 7 publications

(2 citation statements)

References 182 publications

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“…Of similar concern, and perhaps even more important given the increased incidence of polypharmacy, is the need to predict potential DDI in elderly adults. As with pediatric modeling, physiological changes in enzyme and transporter expression levels, together with changes in organ function, can be incorporated into PBPK models (Demeester et al, 2023). To that end, a recent FDA white paper supported the utility of PBPK modeling to predict pharmacokinetic changes in older patients (Liu et al, 2022).…”

Section: Pbpk Modeling Of Ddi In Special Populationsmentioning

confidence: 99%

Utility of PBPK Modeling in Predicting and Characterizing Clinical Drug Interactions

Foti

2024

Drug Metab Dispos

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Physiologically-based pharmacokinetic (PBPK) modeling is a mechanistic dynamic modeling approach that can be used to predict or retrospectively describe changes in drug exposure due to drug-drug interactions. With advancements in commercially available PBPK software, PBPK DDI modeling has become a mainstream approach from early drug discovery through to late stage drug development and is often utilized to support regulatory packages for new drug applications. This minireview will briefly describe the approaches to predicting DDI utilizing PBPK and static modeling approaches, the basic model structures and features inherent to PBPK DDI models and key examples where PBPK DDI models have been used to describe complex DDI mechanisms. Future directions aimed at using PBPK models to characterize transporter-mediated DDI, predict DDI in special populations and assess the DDI potential of protein therapeutics will be discussed. A summary of the 209 PBPK DDI examples published to date in 2023 will be provided. Overall, current data and trends suggest a continued role for PBPK models in the characterization and prediction of DDI for therapeutic molecules.

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Section: Pbpk Modeling Of Ddi In Special Populationsmentioning

confidence: 99%

Utility of PBPK Modeling in Predicting and Characterizing Clinical Drug Interactions

Foti

2024

Drug Metab Dispos

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“…PBPK model integrates drug-specific data (e.g., blood-to-plasma ratio, PPB, permeability) and physiological parameters (e.g., organ blood flow, organ volume, drug-metabolizing enzyme and transporter abundance) to mechanistically predict the PK profile of a drug (Rowland et al, 2011;Rostami-Hodjegan, 2012). PBPK modeling has a wide range of applications, encompassing PK extrapolation to special populations, prediction of drug-drug interactions, optimization of dosage regimen, and assessment of bioequivalence, among other uses (Zhao et al, 2011;Perry et al, 2020;Abouir et al, 2021;Demeester et al, 2023;Manolis et al, 2023). Regulatory agencies such as the US FDA and EMA have emphasized using PBPK modeling to support regulatory submissions for drug development.…”

Section: Pbpk Modeling To Predict Sirna Disposition During Pregnancymentioning

confidence: 99%

The ADME characteristics of siRNA therapeutics and the opportunity to predict disposition in pregnant women.

Amaeze,

Isoherranen,

Shum

2024

Drug Metab Dispos

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In‐Depth Analysis of the Selection of PBPK Modeling Tools: Bibliometric and Social Network Analysis of the Open Systems Pharmacology Community

Dallmann,

Teutonico,

Schaller

et al. 2024

The Journal of Clinical Pharma

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Since the Open Source Initiative laid the foundation for the open source software environment in 1998, the popularity of free and open source software has been steadily increasing. Model‐informed drug discovery and development (MID3), a key component of pharmaceutical research and development, heavily makes use of computational models which can be developed using various software including the Open Systems Pharmacology (OSP) software (PK‐Sim/MoBi), a free and open source software tool for physiologically based pharmacokinetic (PBPK) modeling. In this study, we aimed to investigate the impact, application areas, and reach of the OSP software as well as the relationships and collaboration patterns between organizations having published OSP‐related articles between 2017 and 2023. Therefore, we conducted a bibliometric analysis of OSP‐related publications and a social network analysis of the organizations with which authors of OSP‐related publications were affiliated. On several levels, we found evidence for a significant growth in the size of the OSP community as well as its visibility in the MID3 community since OSP's establishment in 2017. Specifically, the annual publication rate of PubMed‐indexed PBPK‐related articles using the OSP software outpaced that of PBPK‐related articles using any software. Our bibliometric analysis and network analysis demonstrated that the expansion of the OSP community was predominantly driven by new authors and organizations without prior connections to the community involving the generation of research clusters de novo and an overall diversification of the network. These findings suggest an ongoing evolution of the OSP community toward a more segmented, diverse, and inclusive network.

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Physiologically based pharmacokinetic (PBPK) modelling of oral drug absorption in older adults – an AGePOP review

Cited by 7 publications

References 182 publications

Utility of PBPK Modeling in Predicting and Characterizing Clinical Drug Interactions

Utility of PBPK Modeling in Predicting and Characterizing Clinical Drug Interactions

The ADME characteristics of siRNA therapeutics and the opportunity to predict disposition in pregnant women.

In‐Depth Analysis of the Selection of PBPK Modeling Tools: Bibliometric and Social Network Analysis of the Open Systems Pharmacology Community

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