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Considerations for the Forced Expiratory Volume in 1 Second-Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products.
Lee J, Feng K, Conti DS, Walenga R, Wientjes M, Wang H, Newman B, Han L, Dhapare S, Bielski E, Babiskin A, Wu F, Donnelly M, Kim MJ, Jiang W, Luke MC, Fang L, Zhao L. Lee J, et al. Among authors: wu f. Clin Pharmacol Ther. 2022 Nov;112(5):982-989. doi: 10.1002/cpt.2553. Epub 2022 Mar 7. Clin Pharmacol Ther. 2022. PMID: 35133652 Review.
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 physiologically-based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report.
Wu F, Mousa Y, Raines K, Bode C, Tsang YC, Cristofoletti R, Zhang H, Heimbach T, Fang L, Kesisoglou F, Mitra A, Polli J, Kim MJ, Fan J, Zolnik BS, Sun D, Zhang Y, Zhao L. Wu F, et al. CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):585-597. doi: 10.1002/psp4.12907. Epub 2023 Jan 4. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 36530026 Free PMC article. Review.
Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report.
Al Shoyaib A, Riedmaier AE, Kumar A, Roy P, Parrott NJ, Fang L, Tampal N, Yang Y, Jereb R, Zhao L, Wu F. Al Shoyaib A, et al. Among authors: wu f. CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):610-618. doi: 10.1002/psp4.12913. Epub 2023 Jan 16. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 36597353 Free PMC article. Review.
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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