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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Detalles Bibliográficos
Autores principales: Oliva, Alexis, Llabrés, Matías
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Article
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

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8226621/
https://www.ncbi.nlm.nih.gov/pubmed/34205892
http://dx.doi.org/10.3390/ph14060527

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