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Page 1
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.
Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.
Pepin X, Arora S, Borges L, Cano-Vega M, Carducci T, Chatterjee P, Chen G, Cristofoletti R, Dallmann A, Delvadia P, Dressman J, Fotaki N, Gray E, Heimbach T, Holte Ø, Kijima S, Kotzagiorgis E, Lennernäs H, Lindahl A, Loebenberg R, Mackie C, Malamatari M, McAllister M, Mitra A, Moody R, Mudie D, Musuamba Tshinanu F, Polli JE, Rege B, Ren X, Rullo G, Scherholz M, Song I, Stillhart C, Suarez-Sharp S, Tannergren C, Tsakalozou E, Veerasingham S, Wagner C, Seo P. Pepin X, et al. Among authors: rullo g. Mol Pharm. 2024 Aug 5;21(8):3697-3731. doi: 10.1021/acs.molpharmaceut.4c00526. Epub 2024 Jun 30. Mol Pharm. 2024. PMID: 38946085 Free PMC article. Review.
PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report.
Heimbach T, Musuamba Tshinanu F, Raines K, Borges L, Kijima S, Malamatari M, Moody R, Veerasingham S, Seo P, Turner D, Fang L, Stillhart C, Bransford P, Ren X, Patel N, Sperry D, Chen H, Rostami-Hodjegan A, Lukacova V, Sun D, Nguefack JF, Carducci T, Grimstein M, Pepin X, Jamei M, Stamatopoulos K, Li M, Sanghavi M, Tannergren C, Mandula H, Zhao Z, Ju TR, Wagner C, Arora S, Wang M, Rullo G, Mitra A, Kollipara S, Chirumamilla SK, Polli JE, Mackie C. Heimbach T, et al. Among authors: rullo g. Mol Pharm. 2024 Nov 4;21(11):5353-5372. doi: 10.1021/acs.molpharmaceut.4c00758. Epub 2024 Sep 30. Mol Pharm. 2024. PMID: 39348508 Free PMC article. Review.
Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report.
Tannergren C, Arora S, Babiskin A, Borges L, Chatterjee P, Cheng YH, Dallmann A, Govada A, Heimbach T, Hingle M, Kollipara S, Kotzagiorgis E, Lindahl A, Mackie C, Malamatari M, Mitra A, Moody R, Pepin X, Polli J, Raines K, Rullo G, Sanghavi M, Savkur R, Singh R, Sjögren E, Suarez-Sharp S, Thomas S, Veerasingham S, Wei K, Wu F, Xu Y, Yoon M, Rege B. Tannergren C, et al. Among authors: rullo g. Mol Pharm. 2025 Jan 6;22(1):5-27. doi: 10.1021/acs.molpharmaceut.4c01148. Epub 2024 Dec 16. Mol Pharm. 2025. PMID: 39680866 Free PMC article.
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
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