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HomeEURL ECVAM status report on the development, validation and regulatory acceptance of alternative methods and approaches (2018)
Метаданни за публикацията
The European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) is an integral part of the European Commission's Joint Research Centre (JRC). This annual EURL ECVAM status report provides updates on the progress being made in the development, validation and regulatory acceptance of alternative-to-animal methods and approaches and their dissemination. In the areas of toxicology and safety assessment, significant progress has been made in demonstrating how in vitro and computational methods can be combined to 'read-across' toxicological properties between similar chemicals to avoid unnecessary animal testing. Alternative methods are also being increasingly employed for the identification of endocrine disruptors and the assessment of chemical mixtures. However the use of alternative methods alone to fully characterise complex toxicological properties of chemicals, such as chronic systemic health effects, remains a formidable challenge. Recommendations have been published on how to improve multi-centre validation studies of alternative methods for the quality control of vaccines and how the data generated can be used for product specific validation by vaccine manufacturers. Recent advances in the ecotoxicology field include the development of a Threshold of Toxicological Concern approach (eco-TTC) for environmental safety assessment and the use of integrated non-animal methods to predict the bioaccumulation potential of chemicals in fish. Addressing the biomedical research domain, EURL ECVAM launched a major study to review the use of alternative methods and models for understanding biology and disease and for developing novel approaches to diagnosis and therapy. The validation of alternative methods intended for regulatory use has progressed on a number of fronts including novel methods for predicting the skin sensitisation potential of chemicals, assessing the leaching (bioelution) of chemicals from metal alloys, and for determining acute toxicity in fish. Two EURL ECVAM validation studies deal with methods for the identification of endocrine disruptors and involve the EU Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL). Several multi-stakeholder discussions on validation took place in various fora which indicate that although well-established validation principles are still relevant today, the process of validation needs to be continually adapted to keep pace with scientific and technological progress. Reflecting the potential application and impact of emerging organ-on-chip devices, EURL ECVAM conducted an international survey of developers and stakeholders to identify the issues determining end-user confidence and to solicit opinions on how best to approach validation to facilitate uptake and acceptance. The EURL ECVAM Scientific Advisory Committee (ESAC) was renewed during 2018 and one of its first mandated tasks is to deliver an opinion on the scientific validity of antibodies and non-antibody affinity reagents generated using animal-free technologies used in research and diagnostics.
- Публикувано:
- Теми: Медицински и биологични изследвания , Научни и технически изследвания
- Тема: доклад от научно изследване , експеримент върху животни , здравен риск , изследване и развитие , изследователски метод , тестване , токсикология , химически продукт , химическо съединение
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| ISSN 1831-9424 | ISBN 978-92-79-97417-5 | DOI 10.2760/818599 | Каталожен номер KJ-NA-29455-EN-N |
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Електронна книга
Размер:
10 177KB
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| ISSN 1831-9424 | ISBN 978-92-76-07879-1 | DOI 10.2760/858311 | Каталожен номер KJ-NA-29455-EN-E |
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Печатна версия
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| ISSN 1018-5593 | ISBN 978-92-79-97418-2 | DOI 10.2760/792308 | Каталожен номер KJ-NA-29455-EN-C |
- Released on EU publications website:
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