METHOD FOR TESTING BIOEQUIVALENCE OF A DISTRIBUTION DEVICE

摘要

The method verifies 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 (μ_ref) of the parameter over a reference population is deducted; for each reference batch (i), the average (x_BBiref) of the parameter over the samples of the reference batch is determined, and the standard deviation (Ò_BBR) between the averages per batch (x_BBiref) is deducted therefrom; a plurality of samples (26a, 26b) is taken from the tested device; the average (μ_test) of the parameter over the population of the test is deducted; and a mathematical variable is calculated taking into account the average of the reference population (μ_réf), the average of the test population (μ_test) and the standard deviation (_ÒBBR) between the averages per batch (x_BBiref) over the population, and it is compared with a predefined value (Θ).