RETROSPECTIVE EVALUATION OF RELATIVE EXTENT OF ABSORPTION BY THE USE OF PARTIAL AREAS UNDER PLASMA-CONCENTRATION VERSUS TIME CURVES IN BIOEQUIVALENCE STUDIES ON CONVENTIONAL RELEASE PRODUCTS
Kk. Midha et al., RETROSPECTIVE EVALUATION OF RELATIVE EXTENT OF ABSORPTION BY THE USE OF PARTIAL AREAS UNDER PLASMA-CONCENTRATION VERSUS TIME CURVES IN BIOEQUIVALENCE STUDIES ON CONVENTIONAL RELEASE PRODUCTS, European journal of pharmaceutical sciences, 4(6), 1996, pp. 381-384
Retrospective analyses were carried out on 22 analytes involved in nin
e bioequivalence studies on conventional release products, in which 90
% confidence intervals were calculated for partial areas under the pla
sma concentration versus time curves (AUCs) from the first sampling ti
me to AUC(last). The use of par tial areas up to 2X the maximum t(max)
among all subjects in any given study gave the same bioequivalence de
cisions as AUC(last).