Frameworks for evaluation and integration of data in regulatory evaluations: The need for excellence in regulatory toxicology

Abstract

Following a number of published expressions of concern about the reliability of experimental science and the implications of non-reproducibility for regulatory toxicology, the European Risk Forum undertook to consider what practises might improve the basis on which regulatory decisions might be made. Guidelines which may be useful in assessments are presented. The document acknowledges the value of the experimental standards used in most regulatory studies but indicates how these may fail to provide the ‘best outcome’ and how imperfect studies based on outdated views of pathophysiology of disease in H. Sapiens may offer little of predictive value.