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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...
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 |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2022
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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 |
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