Variability of the model-independent AUC: The one sample per individual case

A theory is developed for estimation of a population value of AUC along wit h its standard deviation, in ther case, when only one concentration-time (C -t) sample is available for each individual. This theory is based on model- independent pharmacokinetics. Integration methods are classified due to the ir applicability to the presented approach. The main goal of this work is t o establish a statistical hypothesis-testing procedure which would make sin gle C-t samples usable for bio-equivalence studies. An application of the t heory to a number of integration methods currently in use is analyzed in de tail. A real data illustration is included.