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Drug Shelf Life and Release Limits Estimation Based on Manufacturing Process Capability

Specification limits are the competence regulatory agencies, whereas the release limit is a manufacturer’s internal specification to be applied at the time of batch release to assure that quality attributes will remain within the specification limits until the expiry time. The aim of this work is to...

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Detalles Bibliográficos
Autores principales: Oliva, Alexis, Llabrés, Matías
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10145000/
https://www.ncbi.nlm.nih.gov/pubmed/37111557
http://dx.doi.org/10.3390/pharmaceutics15041070