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Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid.
Algorri M, Acharya A, Bernstein J, Cauchon NS, Chen XH, Huynh-Ba K, Krantz C, Li T, Li Y, McLamore S, Roberts SW, Schwinke D, Shah R, Schirmer A, Strickland H, Tang K, Watson T. Algorri M, et al. Among authors: tang k. AAPS Open. 2022;8(1):19. doi: 10.1186/s41120-022-00066-1. Epub 2022 Dec 5. AAPS Open. 2022. PMID: 36530577 Free PMC article.
Summary workshop report: Facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability/bioequivalence.
Polli JE, Cook JA, Davit BM, Dickinson PA, Argenti D, Barbour N, García-Arieta A, Geoffroy JM, Hartauer K, Li S, Mitra A, Muller FX, Purohit V, Sanchez-Felix M, Skoug JW, Tang K. Polli JE, et al. Among authors: tang k. AAPS J. 2012 Sep;14(3):627-38. doi: 10.1208/s12248-012-9376-z. Epub 2012 Jun 9. AAPS J. 2012. PMID: 22684402 Free PMC article.
5,106 results