Points of Reference in Validation Process

In the validation of toxicological test methods the test results are usually assessed by comparison/correlation with results derived from currently used tests in accordance with existing regulations, policies, guidelines and guidances, and which are, in most cases, animal bioassays. Often, such comparisons bring to light theoretical and practical problems. Therefore, ECVAM considered it timely to dedicate a workshop to the issue of points of reference to be used in the validation of new test methods. The aims of this workshop were to a) review the relevance assessment in validation, and b) develop an approach for the use of references in validation. The participants critically discussed the objectives, methods and limitations of the different approaches when using reference test methods, reference test substances and reference results in the context of the validation of toxicological test methods.

HOFFMANN Sebastian;  EDLER Lutz;  GARDNER Ian;  GRIBALDO Laura;  HARTUNG Thomas;  KLEIN Christoph;  LIEBSCH Manfred;  SAUERLAND Stefan;  SCHECHTMAN Leonard;  STAMMATI Annalaura;  NIKOLAIDIS Efstathios; 

2008-07-31

FRAME

JRC44428

0261-1929,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC44428,