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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: lyapustina s. 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
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. Among authors: lyapustina s. AAPS PharmSciTech. 2007 Nov 2;8(4):E90. doi: 10.1208/pt0804090. AAPS PharmSciTech. 2007. PMID: 18181550 Free PMC article.
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: lyapustina s. 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
Challenges and opportunities in implementing the FDA default parametric tolerance interval two one-sided test for delivered dose uniformity of orally inhaled products.
Larner G, Cooper A, Lyapustina S, Leiner S, Christopher D, Strickland H, Golden M, Delzeit HJ, Friedman EM. Larner G, et al. Among authors: lyapustina s. AAPS PharmSciTech. 2011 Dec;12(4):1144-56. doi: 10.1208/s12249-011-9683-1. Epub 2011 Sep 8. AAPS PharmSciTech. 2011. PMID: 21901649 Free PMC article.
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: lyapustina s. 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
Challenges with developing in vitro dissolution tests for orally inhaled products (OIPs).
Riley T, Christopher D, Arp J, Casazza A, Colombani A, Cooper A, Dey M, Maas J, Mitchell J, Reiners M, Sigari N, Tougas T, Lyapustina S. Riley T, et al. Among authors: lyapustina s. AAPS PharmSciTech. 2012 Sep;13(3):978-89. doi: 10.1208/s12249-012-9822-3. Epub 2012 Jul 14. AAPS PharmSciTech. 2012. PMID: 22798037 Free PMC article. Review.
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