Publications

2024

• Controversy on health-based guidance values for bisphenol A—the need of criteria for studies that serve as a basis for risk assessment
  Leist, M. et al.
• Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility Pamies D. et al
• Revolutionizing developmental neurotoxicity testing – A journey from animal models to advanced in vitro systems Smirnova, L. et al.
• Elements and development processes for test methods in toxicology and human health-relevant life science research Cöllen E. et al.

2023

• Protectiveness of NAM-based hazard assessment – which testing scope is required? Zobl W. et al.
• Toward implementing virtual control groups in nonclinical safety studies Golden E. et al.
• REACH Out-Numbered! The Future of REACH and Animal Numbers Rovida C. et al.
• 4.2 Million and Counting... The Animal Toll for REACH Systemic Toxicity Studies Knight J. et al.
• New approach methodologies in human regulatory toxicology – Not if, but how and when! Schmeisser S. et al.
• A Call for a Human Exposome Project Hartung T.
• Establishment of a human cell-based in vitro battery to assess developmental neurotoxicity hazard of chemicals Blum J. et al.

2022

• The Current Status and Work of Three Rs Centres and Platforms in Europe Neuhaus W. et al.
• Engagement of scientists with the public and policymakers to promote alternative methods von Aulock S. et al.
• On the usefulness of animals as a model system (part II): Considering benefits within distinct use domain Pallocca G. and Leist M.
•  Replacement of animal testing by integrated approaches to testing and assessment (IATA): a call for in vivitrosi Caloni, F. et al.
• The Rise of Three Rs Centres and Platforms in Europe Neuhaus, W. et al.
• On the usefulness of animals as a model system (part I): Overview of criteria and focus on robustness Pallocca, G. et al.
• Next-generation risk assessment of chemicals - Rolling out a human-centric testing strategy to drive 3R implementation: The RISK-HUNT3R project perspective Pallocca, G. et al.
• A framework for chemical safety assessment incorporating new approach methodologies within REACH Ball, N. et al.
• Guidance document on Good Cell and Tissue Culture Practice 2.0 (GCCP 2.0) Pamies, D. et al.

2021

• Continuing animal tests on cosmetic ingredients for REACH in the EU Knight, J. et al.
• Application of the 3Rs principles in the development of pharmaceutical generics Vichare, A. S. et al.
• The state of the scientific revolution in toxicology Hartung, Th. et al.
• Identifying, Naming and Documenting of Test and Tool Compound Stocks Leist M.
• Examination of microcystin neurotoxicity using central and peripheral human neurons Klima S. et al.

2020

• "Chemical concentrations in cell culture compartments (C5) – free concentrations" Kisitu J. et al.
• "Setting the stage for next-generation risk assessment with non-animal approaches: the EU-ToxRisk project experience" Moné M. J. et al.
• "Good Cell and Tissue Culture Practice 2.0 (GCCP 2.0) – Draft for Stakeholder Discussion and Call for Action" Pamies D. et al.
• "Examination of microcystin neurotoxicity using central and peripheral human neurons" Klima S. et al.
• "Harnessing the power of novel animal-free test methods for the development of COVID-19 drugs and vaccines" Busquet F. et al.
• "Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology" Rovida C. et al.
• "New European Union statistics on laboratory animal use – what really counts!" Busquet F. et al.
• "Incorporation of stem cell-derived astrocytes into neuronal organoids to allow neuro-glial interactions in toxicological studies" Bruell M. et al. 
• "Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development" Marx U. et al.
• "Determination of benchmark concentrations and their statistical uncertainty for cytotoxicity test data and functional in vitro assays" Krebs A. et al. 
• "The exposome - a new approach for risk assessment" Sillé FCM. et al.

2019

• "Missing the Difference Between Big Data and Artificial Intelligence in RASAR Versus Traditional QSAR" Luechtefeld T. et al.
• "Chemical concentrations in cell culture compartments (C5) - concentration definitions" Kisitu J. et al.
• "Template for the description of cell-based toxicological test methods to allow evaluation and regulatory use of the data" Krebs A. et al.
• "Development of a neurotoxicity assay that is tuned to detect mitochondrial toxicants" Delp J. et al.
• "Nonanimal Models for Acute Toxicity Evaluations: Applying Data-Driven Profiling and Read-Across" Hartung et al.
• "Optimizing drug discovery by Investigative Toxicology: Current and future trends" Beilmann et al.
• Food for Thought: "Toward Good In Vitro Reporting Standards" Hartung et al.

2018

• "Machine learning of toxicological big data enables read-across structure activity relationships (RASAR) outperforming animal test reproducibility" Luechtefeld et al.
• Food for Thought: "Animal testing and its alternatives – the most important omics is economics" Meigs et al.
• t4-Report: "Recommendation on Test Readiness Criteria for New Approach Methods in Toxicology: Exemplified for Developmental Neurotoxicity" Bal-Price et al.
• "Advanced Good Cell Culture Practice for human primary, stem cell-derived and organoid models as well as microphysiological systems " Pamies et al.
• "Rotenone exerts developmental neurotoxicity in a human brain spheroid model" Pamies et al.
• "Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the US" Hartung T.
• "Stage-specific metabolic features of differentiating neurons: Implications for toxicant sensitivity" Delp et al.
•  "Green Toxicology-Know Early About and Avoid Toxic Product Liabilities" Maertens and Hartung

2017 

• "Good cell culture practices & in vitro toxicology" Eskes et al.
• "Towards a 21st-century roadmap for biomedical research and drug discovery: consensus report and recommendations" Langley et al.
• Food for Thought: "The need for strategic development of safety sciences" Busquet et al.
• "Prediction of liver toxicity and mode of action using metabolomics in vitro in HepG2 cells" Ramirez et al.
• "Computational approaches to chemical hazard assessment" Luechtefeld and Hartung
• "Multi-tissue interactions in an integrated three-tissue organ-on-a-chip platform" Skardal et al.
• "3D Differentiation of LUHMES Cell Line to Study Recovery and Delayed Neurotoxic Effects" Harris et al.
• "Thresholds of Toxicological Concern - Setting a threshold for testing below which there is little concern" Hartung T.
•  Food for Thought: "... the first ten years" Hartung T.
• "The Threshold of Toxicological Concern for prenatal developmental toxicity in rats and rabbits" van Ravenzwaay et al.
• "From in vivo to in vitro: The medical device testing paradigm shift" Kerecman Myers et al.
• "Systems Toxicology II: A Special Issue"Hartung et al.
•  Food for Thought: "Opinion versus evidence for the need to move away from animal testing" Hartung T.
• "Systems Toxicology: Real World Applications and Opportunities" Hartung et al.
• "21st Century Cell Culture for 21st Century Toxicology" Pamies and Hartung

2016

• t4-Report: "Good Cell Culture Practice for stem cells and stem-cell-derived models" Pamies et al.
• "Two Good Read-across Practice workshops. Making it work for you!" Maertens et al.
• "In vitro acute and developmental neurotoxicity screening: an overview of cellular platforms and high-throughput technical possibilities" Schmidt et al.
•  t4-Report: "Reference compounds for alternative test methods to indicate developmental neurotoxicity (DNT) potential of chemicals: example lists and criteria for their selection and use" Aschner et al.
• t4-Report: "Biology-inspired microphysiological system approaches to solve the prediction dilemma of substance testing" Marx et al.
• "Highlight report: Launch of a large integrated European in vitro toxicology project: EU-ToxRisk" Daneshian et al.
• "Considering new methodologies in strategies for safety assessment of foods and food ingredients" Blaauboer et al.
• "Analysis of publically available skin sensitization data from REACH registrations 2008-2014" Luechtefeld et al.
• "Analysis of public oral toxicity data from REACH registrations 2008-2014" Luechtefeld et al.
• "Analysis of Draize eye irritation testing and its prediction by mining publicly available 2008-2014 REACH data" Luechtefeld et al.
• "Global analysis of publicly available safety data for 9,801 substances registered under REACH from 2008-2014" Luechtefeld et al.
•  "A LUHMES 3D dopaminergic neuronal model for neurotoxicity testing allowing long-term exposure and cellular resilience analysis" Smirnova et al.
• "Evidence-based absorption, distribution, metabolism, excretion (ADME) and its interplay with alternative toxicity methods" Tsaioun et al.
• "Brain-on-a-chip model enables analysis of human neuronal differentiation and chemotaxis" Kilic et al.
• "Genetic variability in a frozen batch of MCF-7 cells invisible in routine authentication affecting cell function" Kleensang et al.
• "E-cigarettes and the need and opportunities for alternatives to animal testing" Hartung T.
• Food for Thought: "Making big sense from big data in toxicology by read-across"  Hartung T.
• t4-Report: "Toward Good Read-Across Practice (GRAP) guidance" Ball et al.
• t4-Report: "Supporting read-across using biological data" Zhu et al.

2015

• "Finding opportunities in the area of Alternative Methods to Animal Testing for Romania and inauguration of the Romanian Center for Alternative Test Methods (ROCAM)" Farcal et al.
• "No alternatives? Animal experimentation and the future of research" Daneshian et al.
• "First training on alternatives to animal experimentation in Tunisia"  M’Barek et al.
• t4-Report: "Non-animal models of epithelial barriers (skin, intestine and lung) in research, industrial applications and regulatory toxicology" Gordon et al.
• Food for Thought: "Animal use for science in Europe" Daneshian et al.
• Food for Thought: "Cellular resilience" Smirnova et al.
• Food for Thought: "Toxicity testing in the 21st century beyond environmental chemicals" Rovida et al.
• "Systems Toxicology: The Future of Risk Assessment" Sauer et al.
• International STakeholder NETwork (ISTNET): creating a developmental neurotoxicity (DNT) testing road map for regulatory purposes. Bal-Price et al.
• t4 Workshop Report: "Integrated Testing Strategies (ITS) for safety assessment" Rovida et al.

2014

• Food for Thought: "Green toxicology" Maertens et al.
• "Transcriptional and metabolic adaptation of human neurons to the mitochondrial toxicant MPP(+)" Krug et al.
• Current approaches and future role of high content imaging in safety sciences and drug discovery. van Vliet et al.
• State-of-the-art of 3D cultures (organs-on-a-chip) in safety testing and pathophysiology. Alepee et al.
• "OECD validation study to assess intra- and inter-laboratory reproducibility of the zebrafish embryo toxicity test for acute aquatic toxicity testing" Busquet et al.
• Consensus report on the future of animal-free systemic toxicity testing. Leist et al.
• "ESNATS Conference — The Use of Human Embryonic Stem Cells for Novel Toxicity Testing Approaches" Rovida et al.
• "Alternatives initiative in Sri Lanka: pre- and post-conference workshops at the inaugural scientific conference of the Sri Lanka association for laboratory animal science" Gunatilake et al.
• "Safety evaluations under the proposed US Safe Cosmetics and Personal Care Products Act of 2013: animal use and cost estimates" Knight et al.
• "Food for Thought ...Developmental Neurotoxicity – Challenges in the 21st Century and In Vitro Opportunities" Smirnova et al.
• "Instruments for Assessing Risk of Bias and Other Methodological Criteria of Animal Studies: Omission of Well-Established Methods" Beck at al.

2013

• Test systems of developmental toxicity: state-of-the art and future perspectives. Leist et al.
• A roadmap for hazard monitoring and risk assessment of marine biotoxins on the basis of chemical and biological test systems. Daneshian et al.
• "Evidence for the detection of non-endotoxin pyrogens by the whole blood monocyte activation test" Hasiwa et al.
• "Alternative in vitro methods to characterize the role of endocrine active substances (EASs) in hormone-targeted tissues" Rovida et al.
•  "Advanced tests for skin and respiratory sensitization assessment" Rovida et al.
• Inflammatory findings on species extrapolations: humans are definitely no 70-kg mice. Leist and Hartung
• Metabolomics in toxicology and preclinical research. Ramirez et al.
• "Uncertainty of Testing Methods – What Do We (Want to) Know?" Paparella et al.
• "Alternatives to in vivo tests to detect endocrine disrupting chemicals (EDCs) in fish and amphibians – screening for estrogen, androgen and thyroid hormone disruption" Scholz et al.

2012

• t4-Report: “A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing” Basketter et al.
• "Highlight report: towards the replacement of in vivo repeated dose systemic toxicity testing" Hengstler JG et al.
• "The local lymph node assay (LLNA)" Rovida et al.
• t4-Report: "The use of biomarkers of toxicity for integrating in vitro hazard estimates into risk assessment for humans" Blaauboer et al.
• Novel technologies and an overall strategy to allow hazard assessment and risk prediction of chemicals, cosmetics, and drugs with animal-free methods. Leist et al.

2011

• t4-Report: “Critical evaluation of the use of dogs in biomedical research and testing in Europe” Hasiwa et al.
• t4-Report: “A framework program for the teaching of alternative methods (replacement, reduction, refinement) to animal experimentation” Daneshian et al.
• An expert consortium review of the EC-commissioned report “Alternative (Non-Animal) Methods for Cosmetics Testing: Current Status and Future Prospects – 2010” Hartung et al.
•  "Local Lymph Node Assay: how testing laboratories apply OECD TG 429 for REACH purposes" Costanza Rovida
•  How are reproductive toxicity and developmental toxicity addressed in REACH dossiers? Rovida, et al.

2010

• „Food for thought…Considerations and Guidelines for Basic Test Method Descriptions in Toxicology“ Leist, Efremova, Karreman
• „Food for thought…why no new in vitro tests will be done for REACH by registrants“ Rovida
• "The Center for Alternatives to Animal Testing – Europe (CAAT-EU): a transatlantic bridge for the paradigm shift in toxicology" Daneshian, Leist and Hartung
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2009

• „Food for thought…on Education in Alternative Methods in Toxicology“ Hartung, Blaauboer, Leist
• “Development, validation and applications of the monocyte activation test for pyrogens based on human whole blood” Schindler, von Aulock, Daneshian and Hartung
• „Food for thought…on in silico methods in toxicology“ Hartung, Hoffmann