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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: 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: bielski e. 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.
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: bielski e. 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: 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. Among authors: bielski e. 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.
Sensitivity of Pharmacokinetics to Differences in the Particle Size Distribution for Formulations of Locally Acting Mometasone Furoate Suspension-Based Nasal Sprays.
Amini E, Berger SM, Schilling U, Jiao Y, Chen MJ, Bachhav S, Baumstein SM, Tang Y, Al-Humiari M, Leon Astudillo CE, Drescher S, Iley T, Shur J, Price R, Carrasco C, Conti DS, Delvadia R, Oguntimein O, Witzmann K, Absar M, Luke MC, Boc S, Dhapare S, Saluja B, Bielski E, Newman B, Bulitta JB, Hochhaus G. Amini E, et al. Among authors: bielski e. Mol Pharm. 2023 Nov 6;20(11):5690-5700. doi: 10.1021/acs.molpharmaceut.3c00553. Epub 2023 Sep 29. Mol Pharm. 2023. PMID: 37773975 Clinical Trial.
15 results