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Particle size affects pharmacokinetics of milled oxycodone hydrochloride tablet products following nasal insufflation in nondependent, recreational opioid users.
Raofi S, Kinjo M, Sun D, Li Z, Boyce H, Natarajan K, Frost M, Zhao L, Luke M, Lionberger R, Kelsh D, Kim MJ. Raofi S, et al. Among authors: luke m. Clin Transl Sci. 2021 Sep;14(5):1977-1987. doi: 10.1111/cts.13053. Epub 2021 Jun 2. Clin Transl Sci. 2021. PMID: 33982418 Free PMC article. Clinical Trial.
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: luke mc. 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.
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. 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.
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: luke mc. 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.
249 results