{"title":"An analysis of recent animal use in the Republic of Korea, in an international context: Growth in animal procedures but no real progress on <i>refinement</i>.","authors":"Seeun Park, Goun Park, Chunghyun Kim","doi":"10.1177/02611929261498196","DOIUrl":"https://doi.org/10.1177/02611929261498196","url":null,"abstract":"<p><p>Korea has published an annual national census of laboratory animal use since 2008, but whether growth in the level of oversight reflects progress on the Three Rs (<i>replacement</i>, <i>reduction</i>, <i>refinement</i>), and how Korea compares internationally in these respects, is unclear. In order to investigate this further, six years of Animal and Plant Quarantine Agency (APQA) census data (2019-2024 inclusive), supplemented by press releases where primary reports were incomplete, were analysed descriptively (with data gaps clearly marked). The analysis showed that total animal use rose by 23.8%. Animal use in the most severe pain/distress category (Grade E) increased every year, from 40.1% to 51.5% of total animal use (2019 versus 2024). This opposes declining trends in the EU, Great Britain and Canada, in terms of implementing <i>refinement</i> strategies that shift the animal use into a less severe category. Quality control (QC) testing was already dominant in 2019 (65.8% of regulatory testing) and reached 70.3% in 2024; for 2023-2024, this type of testing was 98.0-98.3% rodent-based, despite the availability of validated <i>in vitro</i> alternatives. An apparent decline in efficacy testing reflects normalisation after the COVID-19 surge, rather than a sustained reduction. Korea's proportion of animal use in the highest-severity category (51.5%; 2,364,100 animals in 2024) is markedly greater than Great Britain's (3.4%; 48,224 in 2024), Canada's (2.6%; 98,441 in 2024) or the EU's (8.5%; 784,048 in 2022), despite a broadly comparable reporting scope (which far exceeds the USA's or Japan's incomplete reporting). The analysis revealed that growth in the comprehensive recording of animal use in Korea has not been matched by progress on <i>refinement</i>, <i>reduction</i> or <i>replacement</i>. Current priorities are identified as: enacting pending legislation on the use of alternative methods; and incentivising the adoption of species-specific approaches, particularly for rodent-based QC assays.</p>","PeriodicalId":55577,"journal":{"name":"Atla-Alternatives To Laboratory Animals","volume":" ","pages":"2611929261498196"},"PeriodicalIF":3.0,"publicationDate":"2026-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149290223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Spotlight on Three Rs Progress.","authors":"","doi":"10.1177/02611929261495684","DOIUrl":"https://doi.org/10.1177/02611929261495684","url":null,"abstract":"","PeriodicalId":55577,"journal":{"name":"Atla-Alternatives To Laboratory Animals","volume":" ","pages":"2611929261495684"},"PeriodicalIF":3.0,"publicationDate":"2026-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149172351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"AI-integrated human-relevant alternatives to animal experimentation in drug development: Toward a predictive translational ecosystem, from <i>in vitro</i> and <i>in silico</i> models to clinical and real-world evidence.","authors":"Prashant N Amale, Dhirendra H Tiwari","doi":"10.1177/02611929261492225","DOIUrl":"https://doi.org/10.1177/02611929261492225","url":null,"abstract":"<p><p>Animal experimentation has long been associated with biomedical research and drug development. However, ethical concerns, limited translatability to humans and high clinical attrition rates (> 90%) necessitate a transition toward human-relevant approaches. Although diverse <i>in vitro</i>, <i>in silico</i> and artificial intelligence (AI)-enabled methodologies have emerged, their integration into a unified, regulatory-acceptable framework remains limited. This review proposes an AI-centred, multi-tier decision-support framework, to enable a phased shift toward animal-reduced and, ultimately, animal-free drug development. Human-relevant platforms (e.g. organoids, microphysiological systems (MPS) and 3D bioprinting), are evaluated for their potential to reproduce selected aspects of human pharmacokinetics, toxicity and disease phenotypes. AI-driven strategies, including pharmacokinetic/pharmacodynamic modelling, quantitative systems pharmacology, digital twins and virtual clinical simulations, support the prediction of individualised responses with multi-omics, imaging and real-world data. Special emphasis is placed on neuropharmacology, where AI-integrated human neural models enhance mechanistic understanding and therapeutic optimisation. Human-based approaches, such as microdosing, non-invasive imaging and real-world evidence, provide validation pathways and strengthen translational reliability. Despite progress, challenges related to technical limitations, data integration, cost and regulatory acceptance persist. To address these gaps, we propose the 'AI-orchestrated Human-Relevant Translational Ecosystem' (AI-HRTE), a conceptual framework integrating experimental, computational and clinical data, to support iterative, AI-assisted decision-making. While this framework offers a structured approach to enhance predictive modelling and reduce animal use in line with the Three Rs principles (i.e. <i>replacement</i>, <i>reduction</i> and <i>refinement</i>), its effectiveness remains hypothetical and requires prospective validation.</p>","PeriodicalId":55577,"journal":{"name":"Atla-Alternatives To Laboratory Animals","volume":" ","pages":"2611929261492225"},"PeriodicalIF":3.0,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149042148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Educational utility of a 3D-printed canine hepatic artery phantom for CT bolus tracking training.","authors":"Keonyeong Min, Dongwoo Chang, Namsoon Lee","doi":"10.1177/02611929261489758","DOIUrl":"https://doi.org/10.1177/02611929261489758","url":null,"abstract":"<p><p>Computed tomography angiography (CTA) is critical for evaluating abdominal diseases in veterinary patients. However, mastering bolus tracking remains a challenge for novice trainees, due to its steep learning curve and narrow temporal window. We evaluated the effectiveness of a 3D-printed canine hepatic artery phantom as a simulator-based training tool to improve technical proficiency in CT bolus tracking. The phantom was integrated into a closed-loop circuit with a peristaltic pump to replicate physiologic contrast kinetics. Eighteen participants, who were stratified by level of experience (A, experienced; B, intermediate; C, beginner), completed three repeated trials of a standardised bolus tracking protocol. Training efficacy was assessed by using objective timing metrics, and subjective pre- and post-training evaluations and subjective Likert scale-based questionnaires. Total operation time significantly decreased in Groups B and C, while Group A showed a non-significant reduction. Significant improvements in region of interest (ROI) placement time were observed across all groups. Furthermore, participants reported significant increases in conceptual understanding, procedural confidence and anatomical recognition. Use of the 3D-printed canine hepatic artery phantom is a feasible ethical alternative to the use of animals for such training purposes, effectively standardising technical proficiency in veterinary radiology. The study findings support the integration of high-fidelity phantom use into veterinary radiology curricula, to bridge the gap between theory and clinical practice.</p>","PeriodicalId":55577,"journal":{"name":"Atla-Alternatives To Laboratory Animals","volume":" ","pages":"2611929261489758"},"PeriodicalIF":3.0,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149013305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ian Crooks, Sara Hurtado, Martha Moore, Tao Chen, Mariano Scian, Robert Leverette, Guy Lalonde, Leon Stankowski, Michael Hollings, Katarina Aleksa, Roman Wieczorek, Hans Raabe, Rodger Curren
{"title":"Key challenges for <i>in vitro</i> testing of tobacco and next generation products for regulatory applications: Recommendations for the Ames test.","authors":"Ian Crooks, Sara Hurtado, Martha Moore, Tao Chen, Mariano Scian, Robert Leverette, Guy Lalonde, Leon Stankowski, Michael Hollings, Katarina Aleksa, Roman Wieczorek, Hans Raabe, Rodger Curren","doi":"10.1177/02611929261489755","DOIUrl":"https://doi.org/10.1177/02611929261489755","url":null,"abstract":"<p><p>The Ames bacterial mutagenesis assay (Ames test) has been used for more than 50 years, to help assess the safety of a variety of single chemicals and complex mixtures in the form of solids, liquids or aerosols. Because of the diverse range of substances that need to be tested, many modifications of this test, as well as modifications of the methods by which the test substances are prepared and applied to the bacterial test system, have been developed. Currently, there is a need for mutagenicity testing of both traditional tobacco products and next generation products (NGPs) such as e-cigarettes, heated tobacco products, tobacco-free nicotine products, oral pouches, etc. There are currently no standardised guidelines that cover the differing, often complex, procedures used by different laboratories to assess NGPs with the Ames test. To address this problem, the Institute for In Vitro Sciences (IIVS) convened a workshop, where representatives of industry, government, academia, contract research organisations (CROs) and non-government organisations (NGOs) could present bespoke experimental techniques and data from their testing platforms. The further aim of the workshop was to help formulate some general guidelines that could be used in the testing of tobacco and nicotine products, to allow better comparisons to be made between laboratories. The workshop discussions also resulted in the identification of some suggested areas for future research activities.</p>","PeriodicalId":55577,"journal":{"name":"Atla-Alternatives To Laboratory Animals","volume":" ","pages":"2611929261489755"},"PeriodicalIF":3.0,"publicationDate":"2026-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149009325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Robert Landsiedel, Susanne N Kolle, Dorothee Funk-Weyer
{"title":"<i>Frustra laborare</i>? Methodological inefficiencies and epistemic limits in toxicological testing.","authors":"Robert Landsiedel, Susanne N Kolle, Dorothee Funk-Weyer","doi":"10.1177/02611929261472447","DOIUrl":"10.1177/02611929261472447","url":null,"abstract":"<p><p>Toxicological testing seeks to enable robust regulatory decisions while reducing uncertainty. Advances in modern biomedical technologies now allow the generation of data at an unprecedented scale and granularity. However, the proliferation of assays and datasets does not in itself translate into decision-relevant knowledge. This <i>Comment</i> article examines when testing turns into a case of <i>frustra laborare</i> - i.e. expending effort without proportional epistemic gain. We argue that exposure realism and toxicokinetic plausibility function as gatekeepers of relevance: mechanistic effects observed only at implausible internal concentrations rarely alter risk characterisation. Likewise, the act of expanding batteries of new approach methodologies (NAMs) without establishing predefined integration rules, inflates false-positive accumulation and amplifies uncertainty. Reproducibility limits and borderline outcomes are structural features of both animal and non-animal methods, and these factors must be quantified rather than obscured. A value-of-information (VoI) view brings much-needed discipline: the value of a test lies in its ability to shift decisions; those that cannot do so, do not meaningfully contribute. Across all domains discussed, reproducibility stands out as the essential constraint - exposure anchoring, probabilistic integration and uncertainty quantification all depend on assays that perform consistently across laboratories. In order for toxicologists to avoid <i>frustra laborare</i>, testing should be aligned with internal exposure, reproducible, and embedded within decision frameworks that yield actionable outcomes.</p>","PeriodicalId":55577,"journal":{"name":"Atla-Alternatives To Laboratory Animals","volume":" ","pages":"285-298"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148610687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}