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Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid

The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Controls (CMC) Community hosted two virtual panel discussions focusing on several novel regulatory review pathways for innovative oncology products: Real-Time Oncology Review (RTOR), Project Orbis, and the Pro...

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Detalles Bibliográficos
Autores principales: Algorri, Marquerita, Acharya, Ajay, Bernstein, James, Cauchon, Nina S., Chen, Xiao Hong, Huynh-Ba, Kim, Krantz, Carol, Li, Tao, Li, Yiwei, McLamore, Sherita, Roberts, Scott W., Schwinke, David, Shah, Rakhi, Schirmer, Andrea, Strickland, Helen, Tang, Kin, Watson, Timothy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9734574/
https://www.ncbi.nlm.nih.gov/pubmed/36530577
http://dx.doi.org/10.1186/s41120-022-00066-1