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 with its standard deviation, in the 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 their applicability to the presented approach. The main goal of this work is to establish a statistical hypothesis-testing procedure which would make single C-t samples usable for bioequivalence studies. An application of the theory to a number of integration methods currently in use is analyzed in detail. A real data illustration is included.
Jawień
W
W
Collegium Medicum of Jagiellonian University, Kraków, Poland.
D019540:Area Under Curve; D006801:Humans; D008954:Models, Biological; D013810:Therapeutic Equivalency