Validation - Lessons Learned from Practical Experience

With 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.

FENTEM Julia Helen;  PRINSEN Menk K.;  SPIELMANN Horst;  WALUM Erik;  BOTHAM Philip A.; 

1996-07-16

JRC13632

https://publications.jrc.ec.europa.eu/repository/handle/JRC13632,