A Biometrics Invited Paper. Estimation of "Safe Doses" in Carcinogenic Experiments

Publisher Website
Google Scholar
Abstract
Statistical methodology for carcinogenic safety testing here developed has the following advantages: Rather than making possibly unwarranted assumptions about a minimum slope in a dose-response relationship, the method represents an objective data-based method of estimating safe doses. It is applicable to any specified permissible risk. Although the model which is used for the estimation of safe doses and their lower confidence points is parametric, it comprises an adequately large number of parameters to allow for differences in the idiosyncracies of suspected carcinogens, host species and to a limited degree for variations in the experimental protocols. The same computer program will cover the analysis of an experiment in which times to tumor were recorded and experiments in which only tumor incidence rates were recorded or mixtures of the two. Better experimentation is rewarded in that the lower confidence limits for the safe doses should be higher and more closely approach the safe dose as the experimental effort increases. The maximum likelihood estimation procedure is sophisticated and has asymptotic optimality properties. It utilizes the latest techniques of convex programming and the computer algorithm is straightforward and fast. Disadvantages of statistical methodologies for carcinogenic testing are discussed.

This publication has 2 references indexed in Scilit: