ArticleToxicology in vitro : an international journal published in association with BIBRA2018
Establishing a systematic framework to characterise in vitro methods for human hepatic metabolic clearance.
Article in Toxicology in vitro : an international journal published in association with BIBRA, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed, 33 citations in OpenAlex.
- Toward internal threshold for toxicological concern: in vitro hepatocyte metabolism testing of 207 chemicals using cryopreserved suspended hepatocytes for physiologically based pharmacokinetic modeling.Toxicological sciences : an official journal of the Society of Toxicology · 2026Article
- On the Utilization and Characterization of External Biotransformation Systems inACS environmental Au · 2026Review
- Scientific Opinion on the application of physiologically based kinetic (PBK) modelling for the quantitative in vitro to in vivo extrapolation (QIVIVE) of developmental neurotoxicity in vitro battery (DNT IVB) data for pesticide active substances.EFSA journal. European Food Safety Authority · 2025Article
- The PrecisionTox chemical library: creation of a chemical collection to discover evolutionary conserved biomolecular signatures of toxicity.Toxicological sciences : an official journal of the Society of Toxicology · 2025Article
- Article
- Advancing understanding of human variability through toxicokinetic modeling, in vitro-in vivo extrapolation, and new approach methodologies.Human genomics · 2024Review
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- Data set of fraction unbound values in the in vitro incubations for metabolic studies for better prediction of human clearance.Database : the journal of biological databases and curation · 2024Article
- Metabolites in the regulatory risk assessment of pesticides in the EU.Frontiers in toxicology · 2023Review
- Identifying xenobiotic metabolites withFrontiers in toxicology · 2023Article
- Using liver models generated from human-induced pluripotent stem cells (iPSCs) for evaluating chemical-induced modifications and disease across liver developmental stages.Toxicology in vitro : an international journal published in association with BIBRA · 2022Review
- Advances in computational methods along the exposure to toxicological response paradigm.Toxicology and applied pharmacology · 2022Article
- Metabolic profiling andToxicology reports · 2022Article
- Scientific Opinion of the Scientific Panel on Plant Protection Products and their Residues (PPR Panel) on testing and interpretation of comparativeEFSA journal. European Food Safety Authority · 2021Article
Corrections and comments
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Authors and funding
19 authors at 11 institutions in 7 countries.
Funding
Abstract
Hepatic metabolic clearance is one of the most important factors driving the overall kinetics of chemicals including substances used in various product categories such as pesticides, biocides, pharmaceuticals, and cosmetics. A large number of in vitro systems from purified isozymes and subcellular organelles to hepatocytes in simple cultures and in complex scaffold setups are available for measuring hepatic metabolic clearance for different applications. However, there is currently no approach for systematically characterising and comparing these in vitro methods in terms of their design, applicability and performance. To address this, existing knowledge in the field of in vitro human hepatic metabolic clearance methods was gathered and analysed in order to establish a framework to systematically characterise methods based on a set of relevant components. An analogous framework would be also applicable for non-human in vitro systems. The components are associated with the biological test systems used (e.g. subcellular or cells), the in vitro method (e.g. number of cells, test item solubility), related analytical techniques, data interpretation methods (based on substrate depletion/metabolite formation), and performance assessments (precision and accuracy of clearance measurements). To facilitate the regulatory acceptance of this class of methods, it is intended that the framework provide the basis of harmonisation work within the OECD.
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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.