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

2021 ◽  
Vol 14 (6) ◽  
pp. 527
Author(s):  
Alexis Oliva ◽  
Matías Llabrés

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 variances of the reference drug product. In this way, the standard deviation used to set QR is equal to the square root of the sum of between-batch variance plus the within-batch variance estimated by the maximum likelihood method. The process of this method, which we call QRML, is as follows. First, the condition of statistical quality control of the manufacture process is tested. Second, confidence intervals for QR bounds lead to an analysis of the reliability of the biosimilarity assessment. Third, after analyzing the molecular weight and dimer content of seven batches of a commercial bevacizumab drug product, we concluded that the QRML method was more reliable than QR.

1994 ◽  
Vol 89 (428) ◽  
pp. 1200-1208 ◽  
Author(s):  
R. C. Gentleman ◽  
M. S. Hamada ◽  
D. E. Matthews ◽  
A. R. Wilson

1945 ◽  
Vol 152 (1) ◽  
pp. 69-75
Author(s):  
J. C. Edwards ◽  
W. A. Bennett

The purpose of the paper is to outline the numerous directions in which improvements can be sought in engineering inspection. It shows how direct improvements in efficiency can be effected by carefully planned methods of recording results, including the use of statistical quality control, by adopting the principles of time and motion study in the planning of flow of work through inspection, and in the design of gauging fixtures and the arrangement of gauges. The importance of correct personnel selection and organization is stressed, as is also the avoidance of duplication of inspection. The paper concludes by quoting figures showing the substantial reductions which have been achieved in the authors' company by a progressive application of the methods described over a period of several years.


Technometrics ◽  
2000 ◽  
Vol 42 (2) ◽  
pp. 221
Author(s):  
Eric R. Ziegel ◽  
Steven M. Zimmerman ◽  
Marjorie L. Icenogle

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