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

• Main Authors: Alba Figuera-Figuera (Author), Marc Suñé-Pou (Author), Pilar Pérez-Lozano (Author), Encarna García-Montoya (Author), Joaquim Amela-Navarro (Author), Josep M. Suñé-Negre (Author)
• Format: Book
• Published: MDPI AG, 2023-07-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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 a...