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Page 1
A General Framework for Assessing In vitro/In vivo Correlation as a Tool for Maximizing the Benefit-Risk Ratio of a Treatment Using a Convolution-Based Modeling Approach.
Gomeni R, Fang LL, Bressolle-Gomeni F, Spencer TJ, Faraone SV, Babiskin A. Gomeni R, et al. Among authors: babiskin a. CPT Pharmacometrics Syst Pharmacol. 2019 Feb;8(2):97-106. doi: 10.1002/psp4.12378. Epub 2019 Feb 5. CPT Pharmacometrics Syst Pharmacol. 2019. PMID: 30659771 Free PMC article.
In Vitro Biopredictive Methods: A Workshop Summary Report.
Pepin XJH, Dressman J, Parrott N, Delvadia P, Mitra A, Zhang X, Babiskin A, Kolhatkar V, Seo P, Taylor LS, Sjögren E, Butler JM, Kostewicz E, Tannergren C, Koziolek M, Kesisoglou F, Dallmann A, Zhao Y, Suarez-Sharp S. Pepin XJH, et al. Among authors: babiskin a. J Pharm Sci. 2021 Feb;110(2):567-583. doi: 10.1016/j.xphs.2020.09.021. Epub 2020 Sep 19. J Pharm Sci. 2021. PMID: 32956678
Research and Education Needs for Complex Generics.
Stern S, Coghlan J, Krishnan V, Raney SG, Babiskin A, Jiang W, Lionberger R, Xu X, Schwendeman A, Polli JE. Stern S, et al. Among authors: babiskin a. Pharm Res. 2021 Dec;38(12):1991-2001. doi: 10.1007/s11095-021-03149-y. Epub 2021 Dec 24. Pharm Res. 2021. PMID: 34950975 Free PMC article.
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: babiskin a. 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.
Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective.
Newman B, Babiskin A, Bielski E, Boc S, Dhapare S, Fang L, Feibus K, Kaviratna A, Li BV, Luke MC, Ma T, Spagnola M, Walenga RL, Wang Z, Zhao L, El-Gendy N, Bertha CM, Abd El-Shafy M, Gaglani DK. Newman B, et al. Among authors: babiskin a. Adv Drug Deliv Rev. 2022 Nov;190:114526. doi: 10.1016/j.addr.2022.114526. Epub 2022 Sep 5. Adv Drug Deliv Rev. 2022. PMID: 36067967 Review.
45 results