Incorporating random effects in biopharmaceutical control strategies

Abstract Objective Random effects are often neglected when defining the control strategy for a biopharmaceutical process. In this article, we present a case study that highlights the importance of considering the variance introduced by random effects in the calculation of proven acceptable ranges (P...

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Bibliographic Details
Main Authors: Thomas Oberleitner, Thomas Zahel, Marco Kunzelmann, Judith Thoma, Christoph Herwig
Format: Article
Language:English
Published: SpringerOpen 2023-02-01
Series:AAPS Open
Subjects:
Online Access:https://doi.org/10.1186/s41120-022-00070-5