ArticleArchives of toxicology2022
Towards best use and regulatory acceptance of generic physiologically based kinetic (PBK) models for in vitro-to-in vivo extrapolation (IVIVE) in chemical risk assessment.
Article in Archives of toxicology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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Who cites it
22 citing papers in PubMed, 38 citations in OpenAlex.
- Applicability of next-generation risk assessment generic PBK models and their performance within the chemical domain.Archives of toxicology · 2026Article
- New approach methodologies for next-generation risk assessment of nanomaterials and nano-enabled products.Nano convergence · 2026Review
- Complex Distribution Phenomena and Plastic Binding of Test Chemicals in Cell Culture Experiments: Exemplification by Tebufenpyrad.International journal of molecular sciences · 2026Article
- Extrapolation of in vitro effect concentrations to in vivo bioavailable concentrations using PBK modelling in humans for two classes of persistent and mobile compounds: triazoles and triazines.Archives of toxicology · 2026Article
- The way forward for assessing the human health safety of cosmetics in the EU: Proceedings of Workshop 2.Archives of toxicology · 2026Article
- Advances in the application of computational toxicology in cosmetic safety assessment.Archives of toxicology · 2026Review
- Advancements and Challenges in Tissue-Engineered Heart Valves: Integrating Biomechanics, Biomaterials, and Biomimetic Design for Functional Maturity.Biomimetics (Basel, Switzerland) · 2026Review
- Extrapolation steps in quantitativeCurrent research in toxicology · 2026Review
- Transferability and Reproducibility of the HepaRG CometChip Assay.Environmental and molecular mutagenesis · 2025Article
- Quantitative in vitro-to-in vivo extrapolation of human adrenergic and trace amine-associated receptor 1 potencies of pre-workout supplement ingredients using physiologically based kinetic modelling-based reverse dosimetry.Archives of toxicology · 2025Article
- From In Vivo Predictive Dissolution to Virtual Bioequivalence: A GastroPlusPharmaceuticals (Basel, Switzerland) · 2025Article
- Next-generation risk assessment: IntegratingNAM journal · 2025Article
- Advancing human health risk assessment: the role of new approach methodologies.Frontiers in toxicology · 2025Review
- Global sensitivity analysis of Open Systems Pharmacology Suite physiologically based pharmacokinetic models.CPT: pharmacometrics & systems pharmacology · 2024Article
- Per- and polyfluoroalkyl substances alter innate immune function: evidence and data gaps.Journal of immunotoxicology · 2024Review
- Article
- Effects of novel flame retardants tris(1,3-dichloro-2-propyl) phosphate (TDCIPP) and triphenyl phosphate (TPhP) on function and homeostasis in human and rat pancreatic beta-cell lines.Archives of toxicology · 2024Article
- Making PBPK models more reproducible in practice.Briefings in bioinformatics · 2024Article
- In vitro to in vivo extrapolation to derive a metabolism factor for estimating the aggregate exposure to salicylic acid after dermal exposure of its esters.Archives of toxicology · 2024Article
- Effects of Aqueous Boundary Layers and Paracellular Transport on the Efflux Ratio as a Measure of Active Transport Across Cell Layers.Pharmaceutics · 2024Article
Corrections and comments
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Authors and funding
18 authors at 14 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
With an increasing need to incorporate new approach methodologies (NAMs) in chemical risk assessment and the concomitant need to phase out animal testing, the interpretation of in vitro assay readouts for quantitative hazard characterisation becomes more important. Physiologically based kinetic (PBK) models, which simulate the fate of chemicals in tissues of the body, play an essential role in extrapolating in vitro effect concentrations to in vivo bioequivalent exposures. As PBK-based testing approaches evolve, it will become essential to standardise PBK modelling approaches towards a consensus approach that can be used in quantitative in vitro-to-in vivo extrapolation (QIVIVE) studies for regulatory chemical risk assessment based on in vitro assays. Based on results of an ECETOC expert workshop, steps are recommended that can improve regulatory adoption: (1) define context and implementation, taking into consideration model complexity for building fit-for-purpose PBK models, (2) harmonise physiological input parameters and their distribution and define criteria for quality chemical-specific parameters, especially in the absence of in vivo data, (3) apply Good Modelling Practices (GMP) to achieve transparency and design a stepwise approach for PBK model development for risk assessors, (4) evaluate model predictions using alternatives to in vivo PK data including read-across approaches, (5) use case studies to facilitate discussions between modellers and regulators of chemical risk assessment. Proof-of-concepts of generic PBK modelling approaches are published in the scientific literature at an increasing rate. Working on the previously proposed steps is, therefore, needed to gain confidence in PBK modelling approaches for regulatory use.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.