ArticleRegulatory toxicology and pharmacology : RTP2017
Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications.
Article in Regulatory toxicology and pharmacology : RTP, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A Systematic Review of Published Physiologically-based Kinetic Models and an Assessment of their Chemical Space Coverage.Alternatives to laboratory animals : ATLA · 2021Pooled it
- Applicability of next-generation risk assessment generic PBK models and their performance within the chemical domain.Archives of toxicology · 2026Article
- CHIASMA: Advancing chemicals and materials safety and sustainability assessments through innovative integration of in vitro and in silico (new approach) methodologies.Computational and structural biotechnology journal · 2025Article
- Development, testing, parameterisation, and calibration of a human PBPK model for the plasticiser, di-(2-ethylhexyl) terephthalate (DEHTP) usingFrontiers in pharmacology · 2023Article
- Development, testing, parameterisation, and calibration of a human PBK model for the plasticiser, di (2-ethylhexyl) adipate (DEHA) usingFrontiers in pharmacology · 2023Article
- Article
- 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.Archives of toxicology · 2022Article
- Are Non-animal Systemic Safety Assessments Protective? A Toolbox and Workflow.Toxicological sciences : an official journal of the Society of Toxicology · 2022Article
- Enhancing the use of exposure science across EU chemical policies as part of the European Exposure Science Strategy 2020-2030.Journal of exposure science & environmental epidemiology · 2022Article
- Studying metabolism with multi-organ chips: new tools for disease modelling, pharmacokinetics and pharmacodynamics.Open biology · 2022Review
- Article
- Assessment of the predictive capacity of a physiologically based kinetic model using a read-across approach.Computational toxicology (Amsterdam, Netherlands) · 2021Article
- Gaining acceptance in next generation PBK modelling approaches for regulatory assessments - An OECD international effort.Computational toxicology (Amsterdam, Netherlands) · 2021Review
- Development, Testing, Parameterisation and Calibration of a Human PBPK Model for the Plasticiser, Di-(2-propylheptyl) Phthalate (DPHP) Using in Silico,Frontiers in pharmacology · 2021Article
- PBPK model reporting template for chemical risk assessment applications.Regulatory toxicology and pharmacology : RTP · 2020Review
- A Next-Generation Risk Assessment Case Study for Coumarin in Cosmetic Products.Toxicological sciences : an official journal of the Society of Toxicology · 2020Article
- Membrane transporter data to support kinetically-informed chemical risk assessment using non-animal methods: Scientific and regulatory perspectives.Environment international · 2019Review
- Next generation physiologically based kinetic (NG-PBK) models in support of regulatory decision making.Computational toxicology (Amsterdam, Netherlands) · 2019Review
- Physiologically based mathematical models of nanomaterials for regulatory toxicology: A review.Computational toxicology (Amsterdam, Netherlands) · 2019Review
- Development, Testing, Parameterization, and Calibration of a Human Physiologically Based Pharmacokinetic Model for the Plasticizer, HexamollFrontiers in pharmacology · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Physiologically based kinetic (PBK) models are used widely throughout a number of working sectors, including academia and industry, to provide insight into the dosimetry related to observed adverse health effects in humans and other species. Use of these models has increased over the last several decades, especially in conjunction with emerging alternative methods to animal testing, such as in vitro studies and data-driven in silico quantitative-structure-activity-relationship (QSAR) predictions. Experimental information derived from these new approach methods can be used as input for model parameters and allows for increased confidence in models for chemicals that did not have in vivo data for model calibration. Despite significant advancements in good modelling practice (GMP) for model development and evaluation, there remains some reluctance among regulatory agencies to use such models during the risk assessment process. Here, the results of a survey disseminated to the modelling community are presented in order to inform the frequency of use and applications of PBK models in science and regulatory submission. Additionally, the survey was designed to identify a network of investigators involved in PBK modelling and knowledgeable of GMP so that they might be contacted in the future for peer review of PBK models, especially in regards to vetting the models to such a degree as to gain a greater acceptance for regulatory purposes.
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What OpenQuestion holds
Registered trials
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.