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

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.,...

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Bibliographic Details
Main Authors: Alexis Oliva (Author), Matías Llabrés (Author)
Format: Book
Published: MDPI AG, 2021-06-01T00:00:00Z.
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3rd Floor Main Library

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