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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| フォーマット: | 図書 |
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MDPI AG,
2021-06-01T00:00:00Z.
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A1234.567 |
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