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dc.contributor.authorFENTEM Julia helenen_GB
dc.contributor.authorPRINSEN Menk k.en_GB
dc.contributor.authorSPIELMANN Horsten_GB
dc.contributor.authorWALUM Eriken_GB
dc.contributor.authorBOTHAM Philip a.en_GB
dc.identifier.citationToxicology in Vitro vol. 9 no. 6 p. 857-862en_GB
dc.description.abstractWith regard to the problems encountered and the experience gained in validation studies conducted in the past, suggestions have been made concerning criteria for the selection of the tests and laboratories to be included in a validation study, the selection and distribution of test chemicals, and procedures for the handing, analysis and interpretation of the resulting ddata. In particular, tests should have been developed to the extent that detailed protocols and standards operating procedures have been produced and evaluated. The laboratories should be chosen on the basis of evidence of their appropriate experience, competence and ability to comply with good laboratory practice (GLP) requirements. The choise of test chemicals depends primarily on the goals of the validation study and on the availability of reliable in vitro toxicity data of high quality. A biostatistician should be involved in the initial design of the validationstudy as well as in the analysis of the resulting data. The quality of the in vivo and in vitro data must be ensured, prior to determining the reproducibility and predictivity of the alternative test.en_GB
dc.description.sponsorshipJRC.(EI)-Environment Instituteen_GB
dc.titleValidation - Lessons Learned from Practical Experienceen_GB
dc.typeArticles in periodicals and booksen_GB
JRC Directorate:Joint Research Centre Historical Collection

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