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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.,...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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MDPI
2021
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8226621/ https://www.ncbi.nlm.nih.gov/pubmed/34205892 http://dx.doi.org/10.3390/ph14060527 |