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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: huynh ba 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.
Evaluating Current Practices in Shelf Life Estimation.
Capen R, Christopher D, Forenzo P, Huynh-Ba K, LeBlond D, Liu O, O'Neill J, Patterson N, Quinlan M, Rajagopalan R, Schwenke J, Stroup W. Capen R, et al. Among authors: huynh ba k. AAPS PharmSciTech. 2018 Feb;19(2):668-680. doi: 10.1208/s12249-017-0880-4. Epub 2017 Sep 25. AAPS PharmSciTech. 2018. PMID: 28948584
Recent trends in product development and regulatory issues on impurities in active pharmaceutical ingredient (API) and drug products. Part 2: Safety considerations of impurities in pharmaceutical products and surveying the impurity landscape.
Alsante KM, Huynh-Ba KC, Baertschi SW, Reed RA, Landis MS, Furness S, Olsen B, Mowery M, Russo K, Iser R, Stephenson GA, Jansen P. Alsante KM, et al. Among authors: huynh ba kc. AAPS PharmSciTech. 2014 Feb;15(1):237-51. doi: 10.1208/s12249-013-0061-z. Epub 2013 Dec 21. AAPS PharmSciTech. 2014. PMID: 24363207 Free PMC article. No abstract available.
Recent trends in product development and regulatory issues on impurities in active pharmaceutical ingredient (API) and drug products. Part 1: Predicting degradation related impurities and impurity considerations for pharmaceutical dosage forms.
Alsante KM, Huynh-Ba K, Baertschi SW, Reed RA, Landis MS, Kleinman MH, Foti C, Rao VM, Meers P, Abend A, Reynolds DW, Joshi BK. Alsante KM, et al. Among authors: huynh ba k. AAPS PharmSciTech. 2014 Feb;15(1):198-212. doi: 10.1208/s12249-013-0047-x. Epub 2013 Nov 27. AAPS PharmSciTech. 2014. PMID: 24281749 Free PMC article. No abstract available.