P. Macheras et al., THE CUTOFF TIME POINT OF THE PARTIAL AREA METHOD FOR ASSESSMENT OF RATE OF ABSORPTION IN BIOEQUIVALENCE STUDIES, Pharmaceutical research, 11(6), 1994, pp. 831-834
The partial area method has been suggested for the assessment of the a
bsorption rate in bioequivalence studies. This paper provides a theore
tical basis for the estimation of the optimal cutoff time point of the
partial areas for drugs with one compartment model disposition. The a
nalysis is performed by using the appropriate equations which relate t
he normalized (in terms of the extent of absorption) partial areas wit
h time expressed in terms of multiples of half-life. Provided that the
quality of experimental data ensures precise estimation of the parame
ters, the t(max) of the formulation with the faster absorption charact
eristics is generally the most practical cutoff time point for calcula
tion of the normalized partial areas, when a drug follows one compartm
ent model disposition with linear absorption.