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3 results on '"Ingrid Langezaal"'

1. OECD workshop consensus report: Ethical considerations with respect to human derived products, specifically human serum, in OECD test guidelines

Author

Miriam N. Jacobs, Jan M. Bult, Kevin Cavanagh, Christophe Chesne, Nathalie Delrue, Jianan Fu, Emma Grange, Ingrid Langezaal, Dominika Misztela, Jenny Murray, Martin Paparella, Gilly Stoddart, Torsten Tonn, Carol Treasure, Masaaki Tsukano, and Rosemary Versteegen

Subjects
human serum, in vitro test methods, human derived reagents, animal-free, xenofree, ethics, Toxicology. Poisons, RA1190-1270
Abstract

The ethical needs and concerns with use and sourcing of human materials, particularly serum, in OECD in vitro test guidelines were explored in a dedicated international workshop held in 2019. The health-related aspects of the donation procedure, including tissue screening, donor health, laboratory work health protection, permission from the donor for commercial use, payment of the donors and the potential for exploitation of low-income populations and data protection of the donors; supply, availability, and competition with clinical needs; traceability of the serum and auditability/GLP needs for the Test Guideline Programme, were examined. Here we provide the recommendations of the workshop with respect to the use of human serum, and potentially other human reagents, specifically with regard to test method development for OECD Test Guideline utility as part of the Mutual Acceptance of Data requirement across all OECD member countries. These include informed donor consent terminology, a checklist of human serum information requirements to be included with the Good Laboratory Practise report, and suitable sources for human serum to ensure waste supplies are used, that can no longer be used for medical purposes, ensuring no competition of supply for essential medical use.

Published
2023
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2. Reliability of the AR-CALUX®In Vitro Method Used to Detect Chemicals with (Anti)Androgen Activity: Results of an International Ring Trial

Author

Anne Milcamps, Ingrid Langezaal, Roman Liska, Jenny Odum, Matthew P. Dent, and Warren Casey

Subjects
Prioritization, validation, Transcriptional Activation, Validation study, AcademicSubjects/SCI01040, AcademicSubjects/MED00305, business.industry, specificity test, Concordance, Reproducibility of Results, Test method, Computational biology, endocrine disruption, Toxicology, Control test, Receptors, Androgen, androgen receptor, Androgen Receptor Antagonists, Androgens, Medicine, CALUX, business, Mode of action, Reliability (statistics), Regulatory Science, Risk Assessment, and Decision Making
Abstract

The AR-CALUX® in vitro method is a reporter gene-based transactivation method where endocrine active chemicals with androgenic or anti-androgenic potential can be detected. Its primary purpose is for screening chemicals for further prioritization and providing mechanistic (endocrine mode of action) information, as defined by the Organisation of Economic Cooperation and Development (OECD) conceptual framework for the testing and assessment of endocrine-disrupting chemicals. This article describes the conduct and results of an international ring trial with 3 EU-NETVAL laboratories and the test method developer. It was organized by EURL ECVAM to validate the method by testing 46 chemicals. A very good reproducibility within and between laboratories was concluded (94.7–100% and 100% concordance of classification) with low within and between laboratory variability (less than 2.5% CV on EC50 values). Moreover, the variability is within the range of other validated, mechanistically similar methods. In comparison to the AR-reference list compiled by ICCVAM, an almost 100% concordance of classifications was obtained. This method allows the detection of the agonist and antagonist properties of a chemical. A specificity control test was developed during the validation study and added to the antagonist assay rendering the assay more specific. A comparison is made with the mechanistically similar methods AR-EcoScreen™ and 22Rv1/MMTV GR-KO TA. The AR-CALUX® method was approved for inclusion in the recently updated OECD test guideline TG458 which incorporates all 3 methods.

Published
2021

3. Strategies to replace in vivo acute systemic toxicity testing: The report and recommendations of ECVAM workshop 50

Author

Pilar Prieto, Cecilia Clemedson, Alessandra Colombo, José V. Castell, Catherine Gosmore, Rodger Curren, Alessandra Gennari, Inge Mangelsdorf, Ingrid Langezaal, Wilfred J.M. Maas, Thomas Hartung, Joan Albert Vericat, S. Coecke, Juan Riego Sintes, Alan M. Goldberg, Christine Van den Berghe, Silvia Casati, Michael P. Ryan, Gabriele Schmuck, Laura Gribaldo, Katherine A. Stitzel, William S. Stokes, Ralph E. Parchment, Gianni Dal Negro, and Iglika Lessigiarska

Subjects
Acute Toxicity Tests, Guidelines as Topic, Physiological Sciences, Cosmetics, Pharmacology, acute toxicity, Guidelines, Toxicology, Animal Testing Alternatives, Median lethal dose, General Biochemistry, Genetics and Molecular Biology, in vivo study, Lethal Dose 50, toxicity testing, In vivo, Toxicity Tests, Toxicity Tests, Acute, media_common.cataloged_instance, Medicine, Animals, European Union, Registries, European union, conference paper, environmental protection, media_common, Cell Death, business.industry, LD 50, Reproducibility of Results, General Medicine, Acute toxicity, United States, Europe, Medical Laboratory Technology, Systemic toxicity, priority journal, Animal Testing Alternative, cytotoxicity, business, Toxicology Health, Mouth Diseases
Published
2004

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