Applications of an Exact NOAEL (No-Observed-Adverse-Effect-Level) Procedure for Dichotomous Data from Animal Experiments

摘要

A statistical method has been developed that utilizes a step-wise hypothesis testing procedure to estimate the distribution of the no-observed-adverse-effect level (NOAEL), and thereby to estimate the expected value of the NOAEL and its variability. The methodology is dependent upon the sum of the dose group sizes, the expected response rates, experimental dose levels, and the type I error rates. The technique may be employed to evaluate the reliability of the NOAEL and to provide a measure of its variability.