ReviewArchives of toxicology2022
A framework for establishing scientific confidence in new approach methodologies.
Review 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 108 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
108 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Triterpenes in breast cancer: a systematic review of preclinical evidence in rodents.Frontiers in pharmacology · 2025Pooled it
- Review of in vitro approaches for assessing the toxicity of chemical stressors across diverse physiological systems.Toxicological sciences : an official journal of the Society of Toxicology · 2026Review
- New approach methodologies in neurotherapeutics development.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Review
- New approach methodologies (NAMs) for preclinical and translational evaluation of mRNA-lipid nanoparticle (LNP) therapeutics.Journal of controlled release : official journal of the Controlled Release Society · 2026Review
- Human in vitro airway models to assess point-of-contact respiratory toxicity of surfactants and derive human equivalent concentrations after single dose exposure.Toxicological sciences : an official journal of the Society of Toxicology · 2026Article
- Comparison of ex vivo placenta perfusion and in vitro BeWo b30 cell models for assessing transfer of developmental and reproductive toxic compounds.Archives of toxicology · 2026Article
- The NAMs conundrum in the current regulatory risk assessment: progress without clarity?Archives of toxicology · 2026Article
- Translational assessment instruments for preclinical to first-in-human decision-making: a scoping review.Journal of translational medicine · 2026Article
- Functional Mapping of Neurodevelopmental Disease Pathways to Key Neurodevelopmental Processes Represented in the Developmental Neurotoxicity In Vitro Testing Battery.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Prioritizing chemicals for developmental neurotoxicity by integrating data from a new approach methods (NAMs) battery covering key cellular events in neurodevelopment.Neurotoxicology · 2026Article
- Evaluating Dermal Bioactivity of Metal Additive Manufacturing Powders Using HumanChemical research in toxicology · 2026Article
- Developmental Toxicity Evaluation of the Dietary Supplement Vinpocetine Using Mouse and Human 3D Gastruloids.Birth defects research · 2026Article
- Persistence Assessment of Chemicals: Trajectories toward New Approach Methodologies (P-NAMs).Environmental science & technology · 2026Review
- The way forward for assessing the human health safety of cosmetics in the EU: Proceedings of Workshop 2.Archives of toxicology · 2026Article
- Organs-on-Chips in Drug Development: Engineering Foundations, Artificial Intelligence, and Clinical Translation.Biosensors · 2026Review
- Alignment of in vitro and in vivo pulmonary inflammation models using crystalline quartz silica.Particle and fibre toxicology · 2026Article
- Application of new approach methods (NAMs) in food safety with considerations for new proteins.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2026Review
- "The Dose Makes the Poison": Relevance of Paracelsus's Principle for Modern Chemical Hazard Assessment with New Approach Methodologies.Environmental science & technology · 2026Article
- Uncertainty-aware machine learning to predict non-cancer human toxicity for the global chemicals market.Nature communications · 2026Article
- Next generation validation for next generation risk assessment.Frontiers in toxicology · 2026Review
48 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
Robust and efficient processes are needed to establish scientific confidence in new approach methodologies (NAMs) if they are to be considered for regulatory applications. NAMs need to be fit for purpose, reliable and, for the assessment of human health effects, provide information relevant to human biology. They must also be independently reviewed and transparently communicated. Ideally, NAM developers should communicate with stakeholders such as regulators and industry to identify the question(s), and specified purpose that the NAM is intended to address, and the context in which it will be used. Assessment of the biological relevance of the NAM should focus on its alignment with human biology, mechanistic understanding, and ability to provide information that leads to health protective decisions, rather than solely comparing NAM-based chemical testing results with those from traditional animal test methods. However, when NAM results are compared to historical animal test results, the variability observed within animal test method results should be used to inform performance benchmarks. Building on previous efforts, this paper proposes a framework comprising five essential elements to establish scientific confidence in NAMs for regulatory use: fitness for purpose, human biological relevance, technical characterization, data integrity and transparency, and independent review. Universal uptake of this framework would facilitate the timely development and use of NAMs by the international community. While this paper focuses on NAMs for assessing human health effects of pesticides and industrial chemicals, many of the suggested elements are expected to apply to other types of chemicals and to ecotoxicological effect assessments.
Indexed as
Identifiers
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.