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Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.
Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan T, Zhao Y, Kotzagiorgis E, Parrott N, Sharan S, Tistaert C, Heimbach T, Zolnik B, Sjögren E, Wu F, Anand O, Kakar S, Li M, Veerasingham S, Kijima S, Lima Santos GM, Ning B, Raines K, Rullo G, Mandula H, Delvadia P, Dressman J, Dickinson PA, Babiskin A. Mitra A, et al. Among authors: rullo g. J Pharm Sci. 2021 Feb;110(2):594-609. doi: 10.1016/j.xphs.2020.10.059. Epub 2020 Nov 3. J Pharm Sci. 2021. PMID: 33152375
Assessing the Relevance of Solution Phase Stress Testing of Solid Dosage Form Drug Products: A Cross-Industry Benchmarking Study.
Campbell JM, Foti C, Wang C, Adams N, Allain LR, Araujo G, Azevedo R, Franca JR, Hicks SR, Hostyn S, Jansen PJ, Kotoni D, Kuemmell A, Marden S, Rullo G, Santos ACO, Sluggett GW, Zelesky T, Baertschi SW. Campbell JM, et al. Among authors: rullo g. J Pharm Sci. 2022 Feb;111(2):298-305. doi: 10.1016/j.xphs.2021.06.012. Epub 2021 Jun 7. J Pharm Sci. 2022. PMID: 34111446
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.
Mackie C, Arora S, Seo P, Moody R, Rege B, Pepin X, Heimbach T, Tannergren C, Mitra A, Suarez-Sharp S, Borges LN, Kijima S, Kotzagiorgis E, Malamatari M, Veerasingham S, Polli JE, Rullo G. Mackie C, et al. Among authors: rullo g. Mol Pharm. 2024 May 6;21(5):2065-2080. doi: 10.1021/acs.molpharmaceut.4c00202. Epub 2024 Apr 10. Mol Pharm. 2024. PMID: 38600804 Free PMC article. Review.