New Quality-Range-Setting Method Based on Between- and Within-Batch Variability for Biosimilarity Assessment.

ABSTRACT: Analytical biosimilarity assessment relies on two implicit conditions. First, the analytical method must meet a set of requirements known as fit for intended use related to trueness and precision. Second, the manufacture of the reference drug product must be under statistical quality control; i.e., the between-batch variability is not larger than the expected within-batch variability. In addition, the quality range (QR) method is based on one sample per batch to avoid biased standard deviations in unbalanced studies. This, together with the small number of reference drug product batches, leads to highly variable QR bounds. In this paper, we propose to set the QR bounds from variance components estimated using a two-level nested linear model, accounting for between- and within-batch varianc

SUBMITTER: Oliva A 

PROVIDER: S-EPMC8226621 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature