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Scientific and regulatory activities initiated by the U.S. food and drug administration to foster approvals of generic dry powder inhalers: Quality perspective.
El-Gendy N, Bertha CM, Abd El-Shafy M, Gaglani DK, Babiskin A, Bielski E, Boc S, Dhapare S, Fang L, Feibus K, Kaviratna A, Li BV, Luke MC, Ma T, Newman B, Spagnola M, Walenga RL, Zhao L. El-Gendy N, et al. Adv Drug Deliv Rev. 2022 Oct;189:114519. doi: 10.1016/j.addr.2022.114519. Epub 2022 Aug 28. Adv Drug Deliv Rev. 2022. PMID: 36038083 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. 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.
Pharmacotherapy and pregnancy: highlights from the Third International Conference for Individualized Pharmacotherapy in Pregnancy.
Haas DM, Gallauresi B, Shields K, Zeitlin D, Clark SM, Hebert MF, Ren Z, Nallani SC, Meslin EM, Feibus KB, Koren G, Goebel WS, Easterling T, Denne SC, Flockhart DA, Renbarger JL. Haas DM, et al. Among authors: feibus kb. Clin Transl Sci. 2011 Jun;4(3):204-9. doi: 10.1111/j.1752-8062.2011.00280.x. Clin Transl Sci. 2011. PMID: 21707952 Free PMC article.