Guidance Document on Good In Vitro Method Practices (GIVIMP)

OECD

doi:10.1787/9789264304796-en

Cited by 165Animal testing and alternativesAgricultural safety and regulationsClinical Laboratory Practices and Quality Control

Guidance Document on Good In Vitro Method Practices (GIVIMP)

OECD·2018·OECD Series on Testing and Assessment

DOI 10.1787/9789264304796-en

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Abstract

The Organisation for Economic Co-operation and Development (OECD) is an intergovernmental organisation in which representatives of 36 industrialised countries in North and South America, Europe and the Asia and Pacific region, as well as the European Commission, meet to co-ordinate and harmonise policies, discuss issues of mutual concern, and work together to respond to international problems.Most of the OECD's work is carried out by more than 200 specialised committees and working groups composed of member country delegates.Observers from several countries with special status at the OECD, and from interested international organisations, attend many of the OECD's workshops and other meetings.Committees and working groups are served by the OECD Secretariat, located in Paris, France, which is organised into directorates and divisions.The Environment, Health and Safety Division publishes free-of-charge documents in twelve different series: Testing and Assessment; Good Laboratory Practice and Compliance Monitoring; Pesticides;

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The current testing paradigm for developmental neurotoxicity mainly relies on results from in vivo guideline studies (OECD TG 426 and OECD TG 443 with DNT cohort).
“The current testing paradigm for DNT mainly relies on results on results from in vivo guideline studies (OECD TG 426 (OECD 2007), OECD TG 443 with DNT cohort (OECD 2018a)).”
From Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology (2025) · cites this paper as OECD 2018a
GIVIMP provides guidance for development and implementation of cellular methods generating data for regulatory safety assessment.
“The document provides guidance for development and implementation of cellular methods generating data for regulatory safety assessment.”
From Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology (2025) · cites this paper as OECD 2018b
Even if imaging technologies are not specifically covered, GIVIMP explains other important aspects related to in vitro methods (e.g., facilities, test systems, reference/control items, SOPs).
“Even if imaging technologies are not specifically covered, other important aspects related to in vitro methods (e.g., facilities, test systems, reference/control items, SOPs) are explained.”
From Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology (2025) · cites this paper as OECD 2018b
The Guidance Document on Good In Vitro Method Practices (GIVIMP) was published by OECD in 2018 (OECD 2018b).
“A significant step forward was the publication of the Guidance Document on Good In Vitro Method Practices (GIVIMP) by OECD in 2018 (OECD 2018b).”
From Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology (2025) · cites this paper as OECD 2018b
Serum is a complex mixture of different factors, which introduces undefined constituents within the culture medium; many of these components have not yet been identified, and in several cases, their effects on cell/tissue cultures are still unknown.
“In addition, serum is a complex mixture of different factors, which introduces undefined constituents within the culture medium. Many of these components have not yet been identified, and in several cases, their effects on cell/tissue cultures are still unknown [18, 20].”
From A worldwide survey on the use of animal‐derived materials and reagents in scientific experimentation (2022) · cites this paper as [18]

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The use of biomarkers of toxicity for integrating in vitro hazard estimates into risk assessment for humans
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An Air–Liquid Interface Culture System for 3D Organoid Culture of Diverse Primary Gastrointestinal Tissues
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Viral contamination of bovine foetal serum and cell cultures
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Test No. 432: In Vitro 3T3 NRU Phototoxicity Test
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Factors influencing nominal effective concentrations of chemical compounds in vitro: cell concentration
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Genetic variability in a frozen batch of MCF-7 cells invisible in routine authentication affecting cell function
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Test No. 442D: In Vitro Skin Sensitisation
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Design and Testing of Electrostatic Aerosol In Vitro Exposure System (EAVES): An Alternative Exposure System for Particles
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Three-dimensional cell culture technique and pathophysiology
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Compilation and use of genetic toxicity historical control data
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High variability of genomic instability and gene expression profiling in different HeLa clones
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Biokinetics in repeated-dosing in vitro drug toxicity studies
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In vitro–in vivo extrapolation: estimation of human serum concentrations of chemicals equivalent to cytotoxic concentrations in vitro
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Physicochemical substance properties as indicators for unreliable exposure in microplate-based bioassays
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Guidance on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials
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Making the Switch: Alternatives to Fetal Bovine Serum for Adipose-Derived Stromal Cell Expansion
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Implementation of the 3Rs (Refinement, Reduction, and Replacement): Validation and Regulatory Acceptance Considerations for Alternative Toxicological Test Methods
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International Guidelines for Bioanalytical Method Validation: A Comparison and Discussion on Current Scenario
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Standardized cell sources and recommendations for good cell culture practices in genotoxicity testing
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Subacute Toxicity of a Mixture of Nine Chemicals in Rats: Detecting Interactive Effects with a Fractionated Two-Level Factorial Design☆
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Test No. 111: Hydrolysis as a Function of pH
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Experimental and Computational Methods Pertaining to Drug Solubility
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Profiling of drugs and environmental chemicals for functional impairment of neural crest migration in a novel stem cell-based test battery
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Tackling reproducibility in academic preclinical drug discovery
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Test No. 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage
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Effects of Solvents and Dosing Procedure on Chemical Toxicity in Cell-Basedin VitroAssays
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Standardisation of defined approaches for skin sensitisation testing to support regulatory use and international adoption: position of the International Cooperation on Alternative Test Methods
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Fitting tissue chips and microphysiological systems into the grand scheme of medicine, biology, pharmacology, and toxicology
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Cell-line authentication demystified
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Mouse cell line authentication
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Test No. 105: Water Solubility
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Gene Activation of the Apoptotic Caspase Cascade Following Cryogenic Storage
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Dissecting coronary angiogenesis: 3D co-culture of cardiomyocytes with endothelial or mesenchymal cells
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Generation of Human Induced Pluripotent Stem (iPS) Cells in Serum- and Feeder-Free Defined Culture and TGF-β1 Regulation of Pluripotency
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The influence of matrix (an)isotropy on cardiomyocyte contraction in engineered cardiac microtissues
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FBS suppresses TGF-β1-induced chondrogenesis in synoviocyte pellet cultures while dexamethasone and dynamic stimuli are beneficial
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Standardization of pluripotent stem cell cultures for toxicity testing
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Cell Culture Contamination
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The need for a worldwide consensus for cell line authentication: Experience implementing a mandatory requirement at the International Journal of Cancer
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Validation of Alternative In Vitro Methods to Animal Testing: Concepts, Challenges, Processes and Tools
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Dispensing Processes Impact Apparent Biological Activity as Determined by Computational and Statistical Analyses
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Human Tissue Ownership and Use in Research: What Laboratorians and Researchers Should Know
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Virome of US bovine calf serum
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Current limitations and future opportunities for prediction of DILI from in vitro
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Measurement of the free concentration of octylphenol in biological samples with negligible depletion-solid phase microextraction (nd-SPME): Analysis of matrix effects
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SNP array profiling of mouse cell lines identifies their strains of origin and reveals cross-contamination and widespread aneuploidy
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Inactivation of viral agents in bovine serum by gamma irradiation
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The current limitations of in vitro genotoxicity testing and their relevance to the in vivo situation
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Test No. 455: Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists
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Human Biosample Authentication Using the High-Throughput, Cost-Effective SNPtraceTM System
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Validation of qualitative methods of analysis that use control samples
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Quality assurance of metabolomics
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Medicines from Animal Cell Culture
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Removal of serum factors by charcoal treatment promotes adipogenesis via a MAPK-dependent pathway
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Best practices for media selection for Mammalian cells
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Achieving Accurate Compound Concentration in Cell-Based Screening: Validation of Acoustic Droplet Ejection Technology
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In vitro kinetics of amiodarone and its major metabolite in two human liver cell models after acute and repeated treatments
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Molecular, phenotypic, and sample-associated data to describe pluripotent stem cell lines and derivatives
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Human mesenchymal stem cells maintain their phenotype, multipotentiality, and genetic stability when cultured using a defined xeno-free human plasma fraction
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A generic Transcriptomics Reporting Framework (TRF) for ‘omics data processing and analysis
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Species identification of animal cells by nested PCR targeted to mitochondrial DNA
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Framework for the quality assurance of ’omics technologies considering GLP requirements
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Development of an in vitro renal epithelial disease state model for xenobiotic toxicity testing
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A Systematic Analysis of PCR Contamination
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Development of a pluripotent stem cell derived neuronal model to identify chemically induced pathway perturbations in relation to neurotoxicity: Effects of CREB pathway inhibition
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Validation of analytical methods in GMP: the disposable Fast Read 102® device, an alternative practical approach for cell counting
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The dosing determines mutagenicity of hydrophobic compounds in the Ames II assay with metabolic transformation: Passive dosing versus solvent spiking
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A 3-D cardiac muscle construct for exploring adult marrow stem cell based myocardial regeneration
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Novel in vitro and mathematical models for the prediction of chemical toxicity
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Development of a negligible depletion-solid phase microextraction method to determine the free concentration of chlorpromazine in aqueous samples containing albumin
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Evaluation and use of disaccharides as energy source in protein-free mammalian cell cultures
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New Scoping Document on in vitro and ex vivo Assays for the Identification of Modulators of Thyroid Hormone Signalling
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Framework for the quantitative weight-of-evidence analysis of ‘omics data for regulatory purposes
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Authentication of African green monkey cell lines using human short tandem repeat markers
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Kinetics and dynamics of cyclosporine A in three hepatic cell culture systems
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To Scientists' Dismay, Mixed-Up Cell Lines Strike Again
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Test No. 123: Partition Coefficient (1-Octanol/Water): Slow-Stirring Method
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Cell Counting
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Test No. 316: Phototransformation of Chemicals in Water – Direct Photolysis
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Phenotypic and functional comparison of optimum culture conditions for upscaling of dental pulp stem cells
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Effects of Serum-Free Culture at the Air–Liquid Interface in a Human Tissue-Engineered Skin Substitute
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Adaptation of the KeratinoSens™ skin sensitization test to animal-product-free cell culture
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Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices
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Microporous Membrane Growth Substrates for Embryonic Stem Cell Culture and Differentiation
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Towards an integrated in vitro strategy for estrogenicity testing
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Good Laboratory Practice — the Why and the How
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A rule-based expert system for chemical prioritization using effects-based chemical categories
Schmieder, P. K., Kolanczyk, R. C., Hornung, M. W., Tapper, M. A., Denny, J. S., Sheedy, B. R., & Aladjov, H. (2014) · SAR and QSAR in environmental research · doi:10.1080/1062936x.2014.898691 · Cited by 29 · see citing works
Good Cell Culture Practice for stem cells and stem-cell-derived models
Pamies, D. (2016) · ALTEX · doi:10.14573/altex.1607121 · Cited by 28 · see citing works
Use of real-time cellular analysis and Plackett-Burman design to develop the serum-free media for PC-3 prostate cancer cells
Zhao, A., Chen, F., Ning, C., Wu, H., Song, H., Wu, Y., Chen, R., Zhou, K., Xu, X., Lu, Y., et al. (2017) · PLoS ONE · doi:10.1371/journal.pone.0185470 · Cited by 28 · see citing works
Interpreting in vitro developmental toxicity test battery results: The consideration of toxicokinetics
Bosgra, S., & Westerhout, J. (2014) · Reproductive Toxicology · doi:10.1016/j.reprotox.2014.11.001 · Cited by 27 · see citing works
Understanding Animal Sera: Considerations for Use in the Production of Biological Therapeutics
Festen, R. (2007) · doi:10.1002/9780470723791.ch4 · Cited by 27 · see citing works
In vitro Cell Culture Model for Toxic Inhaled Chemical Testing
Ahmad, S., Ahmad, A. M., Neeves, K. B., Hendry‐Hofer, T. B., Loader, J. E., White, C. W., & Veress, L. A. (2014) · Journal of Visualized Experiments · doi:10.3791/51539 · Cited by 26 · see citing works
Atlas of Human Pluripotent Stem Cells in Culture
Healy, L. E., & Ruban, L. (2014) · Springer eBooks · doi:10.1007/978-1-4899-7507-2 · Cited by 26 · see citing works
The Application of the Principles of GLP to in vitro Studies
OECD (2004) · OECD series on principles of good laboratory practice and compliance monitoring · doi:10.1787/9789264084971-en · Cited by 25 · see citing works
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Ensuring the Quality of Stem Cell-Derived In Vitro Models for Toxicity Testing
Stacey, G. N., Coecke, S., Price, A., Healy, L. E., Jennings, P., Wilmes, A., Pinset, C., Ingelman‐Sundberg, M., Louisse, J., Haupt, S., et al. (2016) · Advances in experimental medicine and biology · doi:10.1007/978-3-319-33826-2_11 · Cited by 22 · see citing works
Detailed Review Paper on the Use of Metabolising Systems for In Vitro Testing of Endocrine Disruptors
OECD (2014) · OECD series on testing and assessment · doi:10.1787/9789264085497-en · Cited by 22 · see citing works
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Adaptation to serum-free culture of HEK 293T and Huh7.0 cells
Paschoal, J. F. B., Suárez-Patiño, S. F., Bernardino, T. C., de Rezende, A. G., Lemos, M. A. N., Pereira, C. A., & Jorge, S. A. C. (2014) · BMC Proceedings · doi:10.1186/1753-6561-8-s4-p259 · Cited by 22 · see citing works
Practical Aspects of Designing and Conducting Validation Studies Involving Multi-study Trials
Coecke, S., Bernasconi, C., Bowe, G., Bostroem, A.-C., Burton, J., Cole, T., Fortaner, S., Gouliarmou, V., Gray, A., Griesinger, C. B., et al. (2016) · Advances in experimental medicine and biology · doi:10.1007/978-3-319-33826-2_5 · Cited by 22 · see citing works
Upholding science in health, safety and environmental risk assessments and regulations
Aschner, M., Autrup, H. N., Berry, S. C. L., Boobis, A. R., Cohen, S. M., Creppy, E. E., Dekant, W., Doull, J., Galli, C. L., Goodman, J. I., et al. (2016) · Toxicology · doi:10.1016/j.tox.2016.09.005 · Cited by 21 · see citing works
Considerations in the Development of In Vitro Toxicity Testing Methods Intended for Regulatory Use
Coecke, S., Bowe, G., Milcamps, A., Bernasconi, C., Bostroem, A.-C., Bories, G., Fortaner, S., Gineste, J.-M., Gouliarmou, V., Langezaal, I., et al. (2014) · Methods in pharmacology and toxicology · doi:10.1007/978-1-4939-0521-8_25 · Cited by 20 · see citing works
Notes on the use of historical controls.
Yoshimura, I., & Matsumoto, K. (1994) · Environmental Health Perspectives · doi:10.1289/ehp.94102s119 · Cited by 20 · see citing works
Incipient cytotoxicity: A time-independent measure of cytotoxic potency in vitro
Gülden, M., Kähler, D., & Seibert, H. (2015) · Toxicology · doi:10.1016/j.tox.2015.07.002 · Cited by 19 · see citing works
Quality Assurance and GLP
OECD (1999) · OECD series on principles of good laboratory practice and compliance monitoring · doi:10.1787/9789264078598-en · Cited by 19 · see citing works
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Test No. 112: Dissociation Constants in Water
OECD (1981) · OECD guidelines for the testing of chemicals. Section 1: Physical-chemical properties · doi:10.1787/9789264069725-en · Cited by 19 · see citing works
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Test No. 122: Determination of pH, Acidity and Alkalinity
OECD (2013) · OECD guidelines for the testing of chemicals. Section 1: Physical-chemical properties · doi:10.1787/9789264203686-en · Cited by 19 · see citing works
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Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
OECD (2007) · OECD series on principles of good laboratory practice and compliance monitoring · doi:10.1787/9789264084995-en · Cited by 19 · see citing works
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Compliance of Laboratory Suppliers with GLP Principles
OECD (2000) · OECD series on principles of good laboratory practice and compliance monitoring · doi:10.1787/9789264078611-en · Cited by 15 · see citing works
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Test No. 116: Fat Solubility of Solid and Liquid Substances
OECD (1981) · OECD guidelines for the testing of chemicals. Section 1: Physical-chemical properties · doi:10.1787/9789264069800-en · Cited by 14 · see citing works
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OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025
OECD (2016) · OECD series on principles of good laboratory practice and compliance monitoring · doi:10.1787/62d9f44d-en · Cited by 14 · see citing works
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The Role and Responsibility of the Sponsor in the Application of the Principles of GLP
OECD (1998) · OECD series on principles of good laboratory practice and compliance monitoring · doi:10.1787/9789264078734-en · Cited by 13 · see citing works
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Test No. 114: Viscosity of Liquids
OECD (2012) · OECD guidelines for the testing of chemicals. Section 1: Physical-chemical properties · doi:10.1787/9789264185180-en · Cited by 13 · see citing works
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In Vitro Methods for the Prediction of Ocular and Dermal Toxicity
Harbell, J. W., & Raabe, H. (2014) · CRC Press eBooks · doi:10.1201/b16632-6 · Cited by 13 · see citing works
Availability, Standardization and Safety of Human Cells and Tissues for Drug Screening and Testing
Stacey, G. N., & Hartung, T. (2006) · Drug Testing in vitro · doi:10.1002/9783527609611.ch9

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The ECOTOXicology Knowledgebase: A Curated Database of Ecologically Relevant Toxicity Tests to Support Environmental Research and Risk Assessment
Olker, J. H., Elonen, C. M., Pilli, A., Anderson, A., Kinziger, B., Erickson, S., Skopinski, M., Pomplun, A., LaLone, C. A., Russom, C. L., et al. (2022) · Environmental Toxicology and Chemistry · doi:10.1002/etc.5324 · Cited by 317 · see citing works
Biology-inspired microphysiological systems to advance medicines for patient benefit and animal welfare
Marx, U. (2020) · ALTEX · doi:10.14573/altex.2001241 · Cited by 271 · see citing works
Bayer’s in silico ADMET platform: a journey of machine learning over the past two decades
Göller, A. H., Kuhnke, L., Montanari, F., Bonin, A., Schneckener, S., ter Laak, A., Wichard, J., Lobell, M., & Hillisch, A. (2020) · Drug Discovery Today · doi:10.1016/j.drudis.2020.07.001 · Cited by 215 · see citing works
The alamar blue assay in the context of safety testing of nanomaterials
Longhin, E., Yamani, N. E., Rundén‐Pran, E., & Dušinská, M. (2022) · Frontiers in Toxicology · doi:10.3389/ftox.2022.981701 · Cited by 162 · see citing works
A Beginner’s Guide to Cell Culture: Practical Advice for Preventing Needless Problems
Weiskirchen, S., Schröder, S. K., Buhl, E. M., & Weiskirchen, R. (2023) · Cells · doi:10.3390/cells12050682 · Cited by 148 · see citing works
Test No. 442E: In Vitro Skin Sensitisation
OECD (2016) · OECD guidelines for the testing of chemicals. Section 4: Health effects · doi:10.1787/9789264264359-en · Cited by 123 · see citing works
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Research recommendations to better understand the potential health impacts of microplastics to humans and aquatic ecosystems
Hampton, L. M. T., Bouwmeester, H., Brander, S. M., Coffin, S., Cole, M., Hermabessière, L., Mehinto, A. C., Miller, E. L., Rochman, C. M., & Weisberg, S. B. (2022) · Microplastics and Nanoplastics · doi:10.1186/s43591-022-00038-y · Cited by 120 · see citing works
Development of a Roadmap for Action on New Approach Methodologies in Risk Assessment
Escher, S. E., Partosch, F., Konzok, S., Jennings, P., Luijten, M., Kienhuis, A. S., de Leeuw, V. C., Reuss, R., Lindemann, K.-M., & Bennekou, S. H. (2022) · EFSA Supporting Publications · doi:10.2903/sp.efsa.2022.en-7341 · Cited by 108 · see citing works
Guidance document on Good cell and tissue culture practice 2.0 (GCCP 2.0)
Pamies, D. (2021) · ALTEX · doi:10.14573/altex.2111011 · Cited by 100 · see citing works
Human organoids as 3D in vitro platforms for drug discovery: opportunities and challenges
Wang, D., Villenave, R., Stokar‐Regenscheit, N., & Clevers, H. C. (2025) · Nature Reviews Drug Discovery · doi:10.1038/s41573-025-01317-y · Cited by 98 · see citing works
Safer chemicals using less animals: kick-off of the European ONTOX project
Vinken, M., Benfenati, E., Busquet, F., Castell, J. V., Clevert, D.-A., de Kok, T. M. C. M., Dirven, H. A. A. M., Fritsche, E., Geris, L., Gozalbes, R., et al. (2021) · Toxicology · doi:10.1016/j.tox.2021.152846 · Cited by 80 · see citing works
Screening and prioritization of nano- and microplastic particle toxicity studies for evaluating human health risks – development and application of a toxicity study assessment tool
Gouin, T., Ellis‐Hutchings, R. G., Hampton, L. M. T., Lemieux, C. L., & Wright, S. (2022) · Microplastics and Nanoplastics · doi:10.1186/s43591-021-00023-x · Cited by 81 · see citing works
Cell line authentication: a necessity for reproducible biomedical research
Souren, N. Y., Fusenig, N. E., Heck, S., Dirks, W. G., Capes‐Davis, A., Bianchini, F., & Plass, C. (2022) · The EMBO Journal · doi:10.15252/embj.2022111307 · Cited by 73 · see citing works
Inter-laboratory variability of A549 epithelial cells grown under submerged and air-liquid interface conditions
Barošová, H., Meldrum, K., Karakoçak, B. B., Balog, S., Doak, S. H., Petri‐Fink, A., Clift, M. J. D., & Rothen‐Rutishauser, B. (2021) · Toxicology in Vitro · doi:10.1016/j.tiv.2021.105178 · Cited by 71 · see citing works
Advanced in vitro lung-on-chip platforms for inhalation assays: From prospect to pipeline
Artzy‐Schnirman, A., Hobi, N., Schneider‐Daum, N., Guenat, O. T., Lehr, C., & Sznitman, J. (2019) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2019.09.006 · Cited by 69 · see citing works
Optimizing drug discovery by Investigative Toxicology: Current and future trends
Beilmann, M. (2018) · ALTEX · doi:10.14573/altex.1808181 · Cited by 68 · see citing works
Understanding the Development, Standardization, and Validation Process of Alternative In Vitro Test Methods for Regulatory Approval from a Researcher Perspective
Bas, A., Burns, N., Gulotta, A., Junker, J., Drasler, B., Lehner, R., Aicher, L., Constant, S., Petri‐Fink, A., & Rothen‐Rutishauser, B. (2021) · Small · doi:10.1002/smll.202006027 · Cited by 60 · see citing works
Pluripotent Stem Cell Heterogeneity
Hayashi, Y., Ohnuma, K., & Furue, M. K. (2019) · Advances in experimental medicine and biology · doi:10.1007/978-3-030-11096-3_6 · Cited by 59 · see citing works
OECD approaches and considerations for regulatory evaluation of endocrine disruptors
Browne, P., van der Wal, L., & Gourmelon, A. (2019) · Molecular and Cellular Endocrinology · doi:10.1016/j.mce.2019.110675 · Cited by 55 · see citing works
Systematic review of Ethiopian medicinal plants used for their anti-inflammatory and wound healing activities
Nigussie, D., Makonnen, E., Tufa, T. B., Brewster, M., Legesse, B. A., Fekadu, A., & Davey, G. (2021) · Journal of Ethnopharmacology · doi:10.1016/j.jep.2021.114179 · Cited by 54 · see citing works
A pragmatic framework for the application of new approach methodologies in one health toxicological risk assessment
Magurany, K. A., Chang, X., Clewell, R. A., Coecke, S., Haugabrooks, E. M., & Marty, S. (2023) · Toxicological Sciences · doi:10.1093/toxsci/kfad012 · Cited by 58 · see citing works
Advancing Toxicity Predictions: A Review on in Vitro to in Vivo Extrapolation in Next-Generation Risk Assessment
Han, P., Li, X., Yang, J., Zhang, Y., & Chen, J. (2024) · Environment & Health · doi:10.1021/envhealth.4c00043 · Cited by 52 · see citing works
In-vitro digestion models: a critical review for human and fish and a protocol for in-vitro digestion in fish
Wang, R., Mohammadi, M. Y., Mahboubi, A., & Taherzadeh, M. J. (2021) · Bioengineered · doi:10.1080/21655979.2021.1940769 · Cited by 51 · see citing works
A call to action: Advancing new approach methodologies (NAMs) in regulatory toxicology through a unified framework for validation and acceptance
Ouédraogo, G., Alépée, N., Tan, B., & Roper, C. S. (2025) · Regulatory Toxicology and Pharmacology · doi:10.1016/j.yrtph.2025.105904 · Cited by 51 · see citing works
Models using native tracheobronchial mucus in the context of pulmonary drug delivery research: Composition, structure and barrier properties
Huck, B. C., Murgia, X., Frisch, S., Hittinger, M., Hidalgo, A., Loretz, B., & Lehr, C. (2022) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2022.114141 · Cited by 49 · see citing works
The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods
Krebs, A., van Vugt‐Lussenburg, B. M. A., Waldmann, T., Albrecht, W., Boei, J. J. W. A., ter Braak, B., Brajnik, M., Braunbeck, T. A., Brecklinghaus, T., Busquet, F., et al. (2020) · Archives of Toxicology · doi:10.1007/s00204-020-02802-6 · Cited by 49 · see citing works
Scientific Validation of Human Neurosphere Assays for Developmental Neurotoxicity Evaluation
Koch, K., Bartmann, K., Hartmann, J., Kapr, J., Klose, J., Kuchovská, E., Pahl, M., Schlüppmann, K., Zühr, E., & Fritsche, E. (2022) · Frontiers in Toxicology · doi:10.3389/ftox.2022.816370 · Cited by 48 · see citing works
Test No. 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals
OECD (2016) · OECD guidelines for the testing of chemicals. Section 4: Health effects · doi:10.1787/9789264264366-en · Cited by 47 · see citing works
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The future of cultured meat between sustainability expectations and socio-economic challenges
Mancini, M. C., & Antonioli, F. (2022) · Elsevier eBooks · doi:10.1016/b978-0-323-91001-9.00024-4 · Cited by 46 · see citing works
External Scientific Report on the Interpretation of Data from the Developmental Neurotoxicity In Vitro Testing Assays for Use in Integrated Approaches for Testing and Assessment
Crofton, K. M., & Mundy, W. R. (2021) · EFSA Supporting Publications · doi:10.2903/sp.efsa.2021.en-6924 · Cited by 47 · see citing works
Beyond AOPs: A Mechanistic Evaluation of NAMs in DART Testing
Rajagopal, R., Baltazar, M. T., Carmichael, P. L., Dent, M. P., Head, J., Li, H., Müller, I. I., Reynolds, J., Sadh, K., Simpson, W., et al. (2022) · Frontiers in Toxicology · doi:10.3389/ftox.2022.838466 · Cited by 43 · see citing works
Review of New Approach Methodologies for Application in Risk Assessment of Nanoparticles in the Food and Feed Sector: Status and Challenges
Usmani, S. M., Bremer‐Hoffmann, S., Cheyns, K., Cubadda, F., Dumit, V. I., Escher, S. E., Fessard, V., Gutleb, A. C., Léger, T., Liu, Y., et al. (2024) · EFSA Supporting Publications · doi:10.2903/sp.efsa.2024.en-8826 · Cited by 44 · see citing works
Evaluation of a panel of in vitro methods for assessing thyroid receptor β and transthyretin transporter disrupting activities
Collet, B., Simon, E., van der Linden, S., el Abdellaoui, N., Naderman, M., Man, H.-Y., Middelhof, I., van der Burg, B., Besselink, H. T., & Brouwer, A. (2019) · Reproductive Toxicology · doi:10.1016/j.reprotox.2019.05.011 · Cited by 42 · see citing works
A comprehensive review on non-clinical methods to study transfer of medication into breast milk – A contribution from the ConcePTION project
Nauwelaerts, N., Deferm, N., Smits, A., Bernardini, C., Lammens, B., Gandia, P., Panchaud, A., Nordeng, H., Bacci, M. L., Forni, M., et al. (2021) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2020.111038 · Cited by 46 · see citing works
A critical review to identify data gaps and improve risk assessment of bisphenol A alternatives for human health
Mhaouty‐Kodja, S., Zalko, D., Tait, S., Testai, E., Viguié, C., Corsini, E., Grova, N., Buratti, F. M., Cabaton, N. J., Coppola, L., et al. (2024) · Critical Reviews in Toxicology · doi:10.1080/10408444.2024.2388712 · Cited by 41 · see citing works
Maximizing the relevance and reproducibility of A549 cell culture using FBS-free media
Chary, A., Groff, K., Stucki, A., Contal, S., Stoffels, C., Cambier, S., Sharma, M., Gutleb, A. C., & Clippinger, A. J. (2022) · Toxicology in Vitro · doi:10.1016/j.tiv.2022.105423 · Cited by 38 · see citing works
An inter-laboratory effort to harmonize the cell-delivered in vitro dose of aerosolized materials
Bannuscher, A., Schmid, O., Drašler, B., Rohrbasser, A., Braakhuis, H., Meldrum, K., Zwart, E., Gremmer, E. R., Birk, B., Rissel, M., et al. (2022) · NanoImpact · doi:10.1016/j.impact.2022.100439 · Cited by 38 · see citing works
The Material World of 3D‐Bioprinted and Microfluidic‐Chip Models of Human Liver Fibrosis
Carvalho, A. M., Bansal, R., Barrias, C. C., & Sarmento, B. F. C. C. (2023) · Advanced Materials · doi:10.1002/adma.202307673 · Cited by 36 · see citing works
Pharmacokinetics‐On‐a‐Chip: In Vitro Microphysiological Models for Emulating of Drugs ADME
Ramadan, Q., Fardous, R. S., Hazaymeh, R., Alshmmari, S. K., & Zourob, M. M. (2021) · Advanced Biology · doi:10.1002/adbi.202100775 · Cited by 36 · see citing works
Gaining acceptance in next generation PBK modelling approaches for regulatory assessments – An OECD international effort
Paini, A., Tan, Y., Sachana, M., & Worth, A. P. (2021) · Computational Toxicology · doi:10.1016/j.comtox.2021.100163 · Cited by 33 · see citing works
A worldwide survey on the use of animal‐derived materials and reagents in scientific experimentation
Cassotta, M., Bartnicka, J. J., Pistollato, F., Parvatam, S., Weber, T., D'Alessandro, V., Bastos, L. F., & Coecke, S. (2022) · Engineering in Life Sciences · doi:10.1002/elsc.202100167 · Cited by 33 · see citing works
Time-Resolved Freely Dissolved Concentrations of Semivolatile and Hydrophobic Test Chemicals in In Vitro AssaysMeasuring High Losses and Crossover by Headspace Solid-Phase Microextraction
Birch, H., Kramer, N. I., & Mayer, P. (2019) · Chemical Research in Toxicology · doi:10.1021/acs.chemrestox.9b00133 · Cited by 30 · see citing works
Modeling Bioavailable Concentrations in Zebrafish Cell Lines and Embryos Increases the Correlation of Toxicity Potencies across Test Systems
Lungu-Mitea, S., Vogs, C., Carlsson, G., Montag, M., Frieberg, K., Oskarsson, A., & Lundqvist, J. (2020) · Environmental Science & Technology · doi:10.1021/acs.est.0c04872 · Cited by 30 · see citing works
Evaluating confidence in toxicity assessments based on experimental data and in silico predictions
Johnson, C., Anger, L. T., Benigni, R., Bower, D., Bringezu, F., Crofton, K. M., Cronin, M., Cross, K. P., Dettwiler, M., Frericks, M., et al. (2021) · Computational Toxicology · doi:10.1016/j.comtox.2021.100204 · Cited by 29 · see citing works
Human organoids to assess environmental contaminants toxicity and mode of action: towards New Approach Methodologies
Bridgeman, L., Pamies, D., & Frangiamone, M. (2025) · Journal of Hazardous Materials · doi:10.1016/j.jhazmat.2025.139562 · Cited by 28 · see citing works
New approach methodologies in human health risk assessment across European regulatory frameworks: Status quo, barriers and drivers for regulatory acceptance and use
Bearth, A., Roth, N., Jansen, T., Holden, L., Čavoški, A., Consiglio, E. D., Hauzenberger, I., Lee, R., Mombelli, E., Tcheremenskaia, O., et al. (2025) · Environment International · doi:10.1016/j.envint.2025.109279 · Cited by 30 · see citing works
Towards the development of standardised sea turtle primary cell cultures for toxicity testing
Finlayson, K. A., Leusch, F. D. L., Limpus, C. J., & van de Merwe, J. P. (2019) · Ecotoxicology and Environmental Safety · doi:10.1016/j.ecoenv.2019.01.117 · Cited by 25 · see citing works
In vitromodels of human development and their potential application in developmental toxicity testing
Niethammer, M., Burgdorf, T., Wistorf, E., Schönfelder, G., & Kleinsorge, M. (2022) · Development · doi:10.1242/dev.200933 · Cited by 25 · see citing works
The value of organs-on-chip for regulatory safety assessment
Heringa, M. B. (2019) · ALTEX · doi:10.14573/altex.1910111 · Cited by 24 · see citing works
Pharmacokinetic/pharmacodynamic approaches to drug delivery design for inhalation drugs
Matera, M. G., Calzetta, L., Ora, J., Rogliani, P., & Cazzola, M. (2021) · Expert Opinion on Drug Delivery · doi:10.1080/17425247.2021.1873271 · Cited by 23 · see citing works
Systematic evaluation of the evidence for identification of endocrine disrupting properties of Bisphenol F
Wiklund, L., & Beronius, A. (2022) · Toxicology · doi:10.1016/j.tox.2022.153255 · Cited by 24 · see citing works
A template wizard for the cocreation of machine-readable data-reporting to harmonize the evaluation of (nano)materials
Jeliazkova, N., Longhin, E., Yamani, N. E., Rundén‐Pran, E., Moschini, E., Serchi, T., Vrček, I. V., Burgum, M. J., Doak, S. H., Cimpan, M. R., et al. (2024) · Nature Protocols · doi:10.1038/s41596-024-00993-1 · Cited by 23 · see citing works
Caffeinated beverages contribute to a more efficient inflammatory response: Evidence from human and earthworm immune cells
Alves, A. D. O., Weis, G. C. C., Unfer, T. C., Assmann, C. E., Barbisan, F., Azzolin, V. F., Chitolina, B., Duarte, T., Filho, E. E. R., Duarte, M. M. M. F., et al. (2019) · Food and Chemical Toxicology · doi:10.1016/j.fct.2019.110809 · Cited by 21 · see citing works
Minimum information for reporting on the TEER (trans-epithelial/endothelial electrical resistance) assay (MIRTA)
Sharma, M., Huber, E. A., Arnesdotter, E., Behrsing, H. P., Bettmann, A., Brandwein, D., Constant, S., Date, R., Deshpande, A., Fabian, E. J., et al. (2024) · Archives of Toxicology · doi:10.1007/s00204-024-03879-z · Cited by 20 · see citing works
Advanced tissue technologies of blood-brain barrier organoids as high throughput toxicity readouts in drug development
Bell, L., Simonneau, C., Zanini, C., Kassianidou, E., Zundel, C., Neff, R., Steinhuber, B., Tecilla, M., Odermatt, A., Villaseñor, R., et al. (2024) · Heliyon · doi:10.1016/j.heliyon.2024.e40813 · Cited by 20 · see citing works
OECD Studies on Water
OECD (2011) · OECD studies on water · doi:10.1787/22245081 · Cited by 20 · see citing works
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Adaptation of Mammalian Cells to Chemically Defined Media
Marigliani, B., Balottin, L. B. L., & Augusto, E. D. F. P. (2019) · Current Protocols in Toxicology · doi:10.1002/cptx.88 · Cited by 19 · see citing works
Academic application of Good Cell Culture Practice for induced pluripotent stem cells
Tigges, J. (2021) · ALTEX · doi:10.14573/altex.2101221 · Cited by 20 · see citing works
Advances in Animal Models and Cutting-Edge Research in Alternatives: Proceedings of the Third International Conference on 3Rs Research and Progress, Vishakhapatnam, 2022
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Authors: OECD
Corresponding author: OECD
Venue: OECD Series on Testing and Assessment
Publisher: OECD Publishing
Published: 2018-12-10
ISSN: 2077-7876 (ISSN-L)
DOI: 10.1787/9789264304796-en
OpenAlex: W4251582862
Cited by: 161
References: 199
Citations by year: 2026: 29 · 2025: 29 · 2024: 24 · 2023: 12 · 2022: 18 · 2021: 20 · 2020: 11 · 2019: 12 · 2018: 1 · 2017: 1 · 2016: 3
FWCI: 10.38
Type: book
Language: en
Open access: closed
Locations: OECD series on testing and assessment (publishedVersion)
Topics: Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Keywords: in vitro toxicity testing, test reproducibility, test reliability

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