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| From the development of the test, up to acceptance by the authorities. How can we be sure that alternative methods will provide good predictions of results? |
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In the European union the ECVAM (European Center for the Validation of Alternative Methods) takes on the responsibility of validating alternative methods*. The related organisations in the USA are known as the ICCVAM (Interagency Coordinating Committee on the Validation of Alternative Methods).
In the case of a formal validation the relevance, the reliability, and the value of the data for the predictivity of effects will all be judged („relevance, reliability and predictivity of alternative methods“). The procedure is defined by the ECVAM (see literature: Practical Aspects of the Validation of Toxicity Test Procedures, ECVAM Workshop 5). Basically what is required is the implementation of blind studies with exactly predefined test protocols. The actual validation takes place before a the pre-validation phase, in which it is defined which is the most suitable protocoll.
In the last few years a long list of replacement methods have been validated.
A few examples:
• test for contact allergens (LLNA = Murine Local Lymph Node Assay )
• tests for corrosive substances (variuos in vitro models)
• tests für photo toxicity (3T3 Assay)
* Validation: the assessment of the scientific quality of a test.
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| References, links and documents |
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Practical Aspects of the Validation of Toxicity Test Procedures. The Report and Recommendations of ECVAM Workshop 5. ATLA 23; 129 -147, 1995. (658 kb)
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