APPLYING BAILER METHOD FOR AUC CONFIDENCE-INTERVALS TO SPARSE SAMPLING

Bailer (1) developed a method for constructing confidence intervals fo r areas under the concentration-vs-time curve (AUC's) with only one sa mple per subject but with multiple subjects sampled at each of several time points post dose. We have modified this method to account for es timation of the variances. How the need to estimate variances affects study design is discussed. An extension of Bailer's method is proposed where variances are modeled as a function of the means, in order to g et more precise estimates of variances. The modified and extended meth ods are applied to a rat toxicokinetic study with only two rats per ti me point per treatment group.