METHOD FOR BIOEQUIVALENCE TESTING OF A DISPENSING DEVICE

摘要

The method makes it possible to check whether a parameter of a tested device (20) is equivalent to that of a reference device (10). It comprises the following steps: - a plurality of samples (16a, 16b) are taken from the reference device, distributed in batches (15a, 15b) - the average (µref) of the parameter is deduced over a reference population - for each reference lot (i), we determine the average (xBBiref) of the parameter on the samples of the reference lot, and we deduce the standard deviation (σBBR) between the means per lot (xBBiref) - we take a plurality of 'samples (26a, 26b) of the device tested - we deduce the mean (µtest) of the parameter over the population of the test - we calculate a mathematical quantity taking into account the mean of the reference population (µref), the mean of the population (µtest) and the standard deviation (σBBR) between the batch means (xBBiref) on the population and we compare it to a predefined value (θ).