Re-examination of the ED01 study. Review of statistics: the need for realistic statistical models for risk assessment.
The statistical analyses of the ED01 study leave us with the following conclusions: 1) To be realistic, risk assessment using chronic animal studies should be based on time-to-response data and models. 2) Simple standards such as a virtual safe dose and simple models such as the one-hit model or linear extrapolation seem ill-suited as scientific means for risk assessment for such extensive data sets as the ED01 study. 3) The development of new methods for analysis, modeling and risk assessment should be encouraged if future decisions are to be realistically based on chronic animal studies.
D015073:2-Acetylaminofluorene; D000818:Animals; D051379:Mice; D008954:Models, Biological; D009374:Neoplasms, Experimental / Q000139:chemically induced*; D012306:Risk; D013223:Statistics as Topic; D013997:Time Factors
D015073:2-Acetylaminofluorene