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Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report.
Adams WP, Ahrens RC, Chen ML, Christopher D, Chowdhury BA, Conner DP, Dalby R, Fitzgerald K, Hendeles L, Hickey AJ, Hochhaus G, Laube BL, Lucas P, Lee SL, Lyapustina S, Li B, O'Connor D, Parikh N, Parkins DA, Peri P, Pitcairn GR, Riebe M, Roy P, Shah T, Singh GJ, Sharp SS, Suman JD, Weda M, Woodcock J, Yu L. Adams WP, et al. Among authors: hochhaus g. J Aerosol Med Pulm Drug Deliv. 2010 Feb;23(1):1-29. doi: 10.1089/jamp.2009.0803. J Aerosol Med Pulm Drug Deliv. 2010. PMID: 20131983
Role of pharmacokinetics in establishing bioequivalence for orally inhaled drug products: workshop summary report.
O'Connor D, Adams WP, Chen ML, Daley-Yates P, Davis J, Derendorf H, Ducharme MP, Fuglsang A, Herrle M, Hochhaus G, Holmes SM, Lee SL, Li BV, Lyapustina S, Newman S, Oliver M, Patterson B, Peart J, Poochikian G, Roy P, Shah T, Singh GJ, Sharp SS. O'Connor D, et al. Among authors: hochhaus g. J Aerosol Med Pulm Drug Deliv. 2011 Jun;24(3):119-35. doi: 10.1089/jamp.2011.0878. Epub 2011 Mar 31. J Aerosol Med Pulm Drug Deliv. 2011. PMID: 21453049
Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report.
Evans C, Cipolla D, Chesworth T, Agurell E, Ahrens R, Conner D, Dissanayake S, Dolovich M, Doub W, Fuglsang A, García Arieta A, Golden M, Hermann R, Hochhaus G, Holmes S, Lafferty P, Lyapustina S, Nair P, O'Connor D, Parkins D, Peterson I, Reisner C, Sandell D, Singh GJ, Weda M, Watson P. Evans C, et al. Among authors: hochhaus g. J Aerosol Med Pulm Drug Deliv. 2012 Jun;25(3):117-39. doi: 10.1089/jamp.2011.0968. Epub 2012 Mar 13. J Aerosol Med Pulm Drug Deliv. 2012. PMID: 22413806
Pharmacokinetics of Orally Inhaled Drug Products.
Hochhaus G, Horhota S, Hendeles L, Suarez S, Rebello J. Hochhaus G, et al. AAPS J. 2015 May;17(3):769-75. doi: 10.1208/s12248-015-9736-6. Epub 2015 Mar 12. AAPS J. 2015. PMID: 25762449 Free PMC article.
Cascade Impactor Equivalence Testing: Comparison of the Performance of the Modified Chi-Square Ratio Statistic (mCSRS) with the Original CSRS and EMA's Average Bioequivalence Approach.
Kurumaddali A, Christopher D, Sandell D, Strickland H, Morgan B, Bulitta J, Wiggenhorn C, Stein S, Lyapustina S, Hochhaus G. Kurumaddali A, et al. Among authors: hochhaus g. AAPS PharmSciTech. 2019 Jul 8;20(6):249. doi: 10.1208/s12249-019-1443-7. AAPS PharmSciTech. 2019. PMID: 31286316
Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?
Hochhaus G, Chen MJ, Kurumaddali A, Schilling U, Jiao Y, Drescher SK, Amini E, Berger SM, Kandala B, Tabulov C, Shao J, Seay B, Abu-Hasan MN, Baumstein SM, Winner L, Shur J, Price R, Hindle M, Wei X, Carrasco C, Sandell D, Oguntimein O, Kinjo M, Delvadia R, Saluja B, Lee SL, Conti DS, Bulitta JB. Hochhaus G, et al. AAPS J. 2021 Mar 25;23(3):48. doi: 10.1208/s12248-021-00569-x. AAPS J. 2021. PMID: 33768368 Free PMC article. Clinical Trial.
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: hochhaus g. 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.
177 results