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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: wu f. 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
Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview.
Babiskin A, Wu F, Mousa Y, Tan ML, Tsakalozou E, Walenga RL, Yoon M, Raney SG, Polli JE, Schwendeman A, Krishnan V, Fang L, Zhao L. Babiskin A, et al. Among authors: wu f. CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):619-623. doi: 10.1002/psp4.12920. Epub 2023 Feb 5. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 36631942 Free PMC article. Review.
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