ArticleFrontiers in cell and developmental biology2021
Validation, Optimization, and Application of the Zebrafish Developmental Toxicity Assay for Pharmaceuticals Under the ICH S5(R3) Guideline.
Article in Frontiers in cell and developmental biology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.
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Who cites it
27 citing papers in PubMed.
- Zebrafish swimming towards cures: a scalable NAM platform for drug discovery.Drug discovery today · 2026Review
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- Comparative analysis of teratogen-induced malformations and gene expression across zebrafish strains in early development.Toxicology reports · 2025Article
- Chemical-induced heart defects using a transgenic zebrafish model.Toxicological sciences : an official journal of the Society of Toxicology · 2025Article
- Detection of developmental toxicity of the anti-COVID-19 drug molnupiravir using gastruloid-based in vitro assays.Toxicological sciences : an official journal of the Society of Toxicology · 2025Article
- Potential Antioxidant and Neuroprotective Effect of Polysaccharide Isolated from DigüeñeJournal of fungi (Basel, Switzerland) · 2025Article
- Effects ofMolecules (Basel, Switzerland) · 2025Article
- Swimming Into View: Zebrafish Uncover Targets, Mechanisms, and Therapies for Cadmium Toxicity.Current environmental health reports · 2025Review
- Unravelling the developmental toxicity of heavy metals using zebrafish as a model: a narrative review.Biometals : an international journal on the role of metal ions in biology, biochemistry, and medicine · 2025Review
- Hepatotoxicity Evaluation of Levornidazole and Its Three Main Impurities: Based on Structure-Toxicity Classification Prediction Combined with Zebrafish Toxicity Assessment.Molecules (Basel, Switzerland) · 2025Article
- Increasingly efficient chromatin binding of cohesin and CTCF supports chromatin architecture formation during zebrafish embryogenesis.Nature communications · 2025Article
- Lactobacillus gasseri LGV03-derived indole-3-lactic acid ameliorates immune response by activating aryl hydrocarbon receptor.Microbial cell factories · 2025Article
- Review
- Organic fertilizer integrated with marine waste derived CaCOScientific reports · 2024Article
- Different Biocompatibility and Radioprotective Activity of Squid Melanin Nanoparticles on Human Stromal Cells.ACS omega · 2024Article
- A high-throughput system for drug screening based on the movement analysis of zebrafish.Heliyon · 2024Article
- Development of an AI-Assisted Embryo Selection System Using Iberian Ribbed Newts for Embryo-Fetal Development Toxicity Testing.Yonago acta medica · 2024Article
- Zebrafish Model in Illuminating the Complexities of Post-Traumatic Stress Disorders: A Unique Research Tool.International journal of molecular sciences · 2024Review
- Article
- Safety and efficacy evaluation of halicin as an effective drug for inhibiting intestinal infections.Frontiers in pharmacology · 2024Article
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11 authors.
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Abstract
The zebrafish as an alternative animal model for developmental toxicity testing has been extensively investigated, but its assay protocol was not harmonized yet. This study has validated and optimized the zebrafish developmental toxicity assay previously reported by multiple inter-laboratory studies in the United States and Europe. In this study, using this classical protocol, of 31 ICH-positive compounds, 23 compounds (74.2%) were teratogenic in zebrafish, five had false-negative results, and three were neither teratogenic nor non-teratogenic according to the protocol standard; of 14 ICH-negative compounds, 12 compounds (85.7%) were non-teratogenic in zebrafish and two had false-positive results. After we added an additional TI value in the zebrafish treated with testing compounds at 2 dpf along with the original 5 dpf, proposed a new category as the uncategorized compounds for those TI values smaller than the cutoff both at 2 dpf and 5 dpf but inducing toxic phenotypes, refined the testing concentration ranges, and optimized the TI cut-off value from ≥ 10 to ≥ 3 for compounds with refined testing concentrations, this optimized zebrafish developmental assay reached 90.3% sensitivity (28/31 positive compounds were teratogenic in zebrafish) and 88.9% (40/45) overall predictability. Our results from this study strongly support the use of zebrafish as an alternative
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