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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...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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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 |