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SeDeM as a Tool to Validate Drug Substance Manufacturing Processes and Assess Scalability and Suitability for Direct Compression: Supplier Screening

During the development of an oral solid form of a drug substance, a thorough understanding of the critical material attributes is necessary, as the physical properties of the active pharmaceutical ingredient (API) can profoundly influence the drug product’s manufacturability, critical quality attrib...

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Detalles Bibliográficos
Autores principales: Figuera-Figuera, Alba, Suñé-Pou, Marc, Pérez-Lozano, Pilar, García-Montoya, Encarna, Amela-Navarro, Joaquim, Suñé-Negre, Josep M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10457849/
https://www.ncbi.nlm.nih.gov/pubmed/37631248
http://dx.doi.org/10.3390/pharmaceutics15082034