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Mechanistic modeling of generic orally inhaled drug products: A workshop summary report.
Walenga RL, Butler C, Craven BA, Longest PW, Mohamed R, Newman B, Olsson B, Hochhaus G, Li BV, Luke MC, Zhao L, Przekwas A, Lionberger R. Walenga RL, et al. Among authors: newman b. CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):560-574. doi: 10.1002/psp4.12889. Epub 2022 Dec 20. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 36330693 Free PMC article. 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: newman b. 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: newman b. 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.
Heat effects on drug delivery across human skin.
Hao J, Ghosh P, Li SK, Newman B, Kasting GB, Raney SG. Hao J, et al. Among authors: newman b. Expert Opin Drug Deliv. 2016;13(5):755-68. doi: 10.1517/17425247.2016.1136286. Epub 2016 Jan 25. Expert Opin Drug Deliv. 2016. PMID: 26808472 Free PMC article. Review.
941 results