In May 2019, the Food and Drug Administration (FDA) proposed a quality range (QR) method\nfor the comparative analytical assessment in biosimilar studies. In this process, several reference\nproduct lots are necessary, selected from a wide period of manufacturing dates with different shelf lives,\nto calculate the total variability expressed as the standard deviation of reference product lots. This one\ndepends on the between-lots variation and analytic method uncertainty (i.e., within-lots variation).\nDuring this time, the analytical method must be in control and stable but with an appropriate accuracy\nand precision. In such a situation, various control charts were used to fix the method requirements and\ndetect small changes in the process. The results indicate that the method is indeed in control and stable,\nbut does not meet the requirements of the Analytical Target Profile (ATP) approach, independently of\nthe established uncertainty range. However, it does satisfy the traditional approach for an uncertainty\nrange���������.
Loading....