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

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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Bibliographic Details
Main Authors: Alba Figuera-Figuera, Marc Suñé-Pou, Pilar Pérez-Lozano, Encarna García-Montoya, Joaquim Amela-Navarro, Josep M. Suñé-Negre
Format: Article
Language:English
Published: MDPI AG 2023-07-01
Series:Pharmaceutics
Subjects:
drug substance manufacturers
particle size
SeDeM expert system
critical quality attribute
critical material attribute
direct compression
Online Access:https://www.mdpi.com/1999-4923/15/8/2034

Internet

https://www.mdpi.com/1999-4923/15/8/2034

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