Regulatory considerations for generic products of non-biological complex drugs

The Non-Biological Complex Drug (NBCD) Working Group defines an NBCD as “a medicinal product, not being a biological medicine, where the active substance is not a homo-molecular structure, but consists of different (closely related and often nanoparticulate) structures that cannot be isolated and fu...

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Detalles Bibliográficos
Autores principales: Liu, Yu-Hsuan, Chen, Yi-Shuo, Tseng, Ting, Jiang, Min-Lin, Gau, Churn-Shiouh, Chang, Lin-Chau
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taiwan Food and Drug Administration 2023
Materias:
Review Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10208665/
https://www.ncbi.nlm.nih.gov/pubmed/37224550
http://dx.doi.org/10.38212/2224-6614.3441

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10208665/
https://www.ncbi.nlm.nih.gov/pubmed/37224550
http://dx.doi.org/10.38212/2224-6614.3441

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