Regulation of phage therapy medicinal products: developments, challenges, and opportunities

Due to their biological properties, bacteriophages represent a regulatory specialty and, at the same time, a challenge with regard to medicinal product approval. Established European guidelines on pharmaceutical quality, preclinical development, and clinical development are only partially applicable...

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Detalles Bibliográficos
Autores principales: Miriam Fuerst-Wilmes, Vanessa Respondek, Michael Schramm, Nils Lilienthal, Katrin Buss, Anja Duechting
Formato: Artigo
Lenguaje:Inglês
Publicado: Frontiers Media S.A. 2025-10-01
Colección:Frontiers in Cellular and Infection Microbiology
Materias:
bacteriophages
phage therapy medicinal products
regulatory advice
antimicrobial resistance
antibacterial treatment
non-traditional product
Acceso en línea:https://www.frontiersin.org/articles/10.3389/fcimb.2025.1631359/full
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