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Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols. Part 3. Final report on a statistical procedure for determining equivalence.
Christopher D, Adams W, Amann A, Bertha C, Byron PR, Doub W, Dunbar C, Hauck W, Lyapustina S, Mitchell J, Morgan B, Nichols S, Pan Z, Singh GJ, Tougas T, Tsong Y, Wolff R, Wyka B. Christopher D, et al. AAPS PharmSciTech. 2007 Nov 2;8(4):E90. doi: 10.1208/pt0804090. AAPS PharmSciTech. 2007. PMID: 18181550 Free PMC article.
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: bertha cm. 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.
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: bertha cm. 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.
16 results