The OSIRIS Weight of Evidence approach: ITS for the endpoints repeated-dose toxicity (RepDose ITS)
| Autor: | Ralph Kühne, Tom Aldenberg, Monika Batke, Inga Tluczkiewicz, Harrie Buist, Sylvia Escher, Dinant Kroese, Eduard Pauné, Inge Mangelsdorf, Helvi Grimm, Gerrit Schüürmann |
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| Přispěvatelé: | Publica, TNO Kwaliteit van Leven |
| Rok vydání: | 2013 |
| Předmět: |
3R principle
Alternative Operations research Integration testing media_common.quotation_subject Biomedical Innovation Weighting Toxicology Risk Assessment Hazardous Substances Documentation Life Toxicity Tests Integrated Testing Strategy Animals Quality (business) OSIRIS Biology Reliability (statistics) media_common Scope (project management) non-testing method repeated-dose risk assessment Repeated-dose General Medicine Guideline integrated testing strategy Risk analysis (engineering) Non-testing method weighting QS - Quality & Safety EELS - Earth Environmental and Life Sciences ITS Risk assessment Healthy Living Software TTC alternative |
| Zdroj: | Regulatory Toxicology and Pharmacology, 2, 67, 157-169 |
| ISSN: | 0273-2300 |
| DOI: | 10.1016/j.yrtph.2013.02.004 |
| Popis: | In the FP6 European project OSIRIS, Integrated Testing Strategies (ITSs) for relevant toxicological endpoints were developed to avoid new animal testing and thus to reduce time and costs. The present paper describes the development of an ITS for repeated-dose toxicity called RepDose ITS which evaluates the conditions under which in vivo non-guideline studies are reliable. In a tiered approach three aspects of these "non-guideline" studies are assessed: the documentation of the study (reliability), the quality of the study design (adequacy) and the scope of examination (validity).The reliability is addressed by the method "Knock-out criteria", which consists of four essential criteria for repeated-dose toxicity studies. A second tool, termed QUANTOS (Quality Assessment of Non-guideline Toxicity Studies), evaluates and weights the adequacy of the study by using intra-criterion and inter-criteria weighting. Finally, the Coverage approach calculates a probability that the detected Lowest-Observed-Effect-Level (LOEL) is similar to the LOEL of a guideline study dependent on the examined targets and organs of the non-guideline study. If the validity and adequacy of the non-guideline study are insufficient for risk assessment, the ITS proposes to apply category approach or the Threshold of Toxicological Concern (TTC) concept, and only as a last resort new animal-testing. © 2013 Elsevier Inc. |
| Databáze: | OpenAIRE |
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