ArticleEFSA journal. European Food Safety Authority2025
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.
Article in EFSA journal. European Food Safety Authority, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Integrating mechanistic data to contextualize in vivo apical observations using the developmental neurotoxicity in vitro battery.Toxicological sciences : an official journal of the Society of Toxicology · 2026Article
- New approach methodologies for next-generation risk assessment of nanomaterials and nano-enabled products.Nano convergence · 2026Review
- Scientific Opinion on waiving of the dog studies in the regulatory process of agrochemicals approval.EFSA journal. European Food Safety Authority · 2026Article
- The Role of ES&T in Advancing Environmental Toxicology and Chemical Risk Assessment: Past, Present, and Future.Environmental science & technology · 2026Review
- Chemical Profiling, Molecular Docking, and Mechanistic Anticancer Activity ofMolecules (Basel, Switzerland) · 2026Article
- 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
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Abstract
EFSA requested the Panel on Plant Protection Products and their Residues (PPR Panel) to produce a Scientific Opinion on the application of physiologically based kinetic (PBK) modelling for the quantitative in vitro to in vivo extrapolation (QIVIVE) of data from the 17-assay developmental neurotoxicity in vitro battery (DNT IVB) for pesticide active substances. PBK modelling-supported QIVIVE is essential for the integration of in vitro data in hazard and risk assessment and may be conducted via forward dosimetry (estimating internal exposure from external exposure to a chemical) or reverse dosimetry (deriving an external exposure from an internal exposure). The request was accomplished via targeted expert discussions and EFSA-internal and -external review. A scientifically robust QIVIVE requires accurate characterisation of two interrelated exposure metrics: the in vitro concentration eliciting a biological response (e.g. free or cellular concentration) and the corresponding in vivo internal concentration predicted by PBK modelling that reflects the same biologically relevant exposure. These metrics are influenced by chemical-specific properties, assay design and physiological variability, requiring a case-by-case assessment of uncertainties. Each QIVIVE assessment should include, as a minimum, a low-tier PBK model using conservative assumptions to avoid underestimation of internal exposure. Where sufficient kinetic data exist, higher tier models may be applied to enhance prediction accuracy. All modelling parameters, assumptions and validation steps must be transparently documented to facilitate regulatory appraisal. QIVIVE outcomes are to be documented in the overall weight of evidence for the DNT assessment. The PPR Panel identified the following three key uncertainty domains: (a) defining the appropriate in vitro exposure metric, (b) predicting internal exposure metrics via PBK modelling and (c) aligning PBK modelling-derived internal exposure with the in vitro exposure. Addressing these uncertainties will strengthen regulatory confidence in using DNT IVB data for hazard and risk assessment of pesticide active substances.
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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 Socratic graph.