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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: christopher d. 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. AAPS PharmSciTech. 2007 Nov 2;8(4):E90. doi: 10.1208/pt0804090. AAPS PharmSciTech. 2007. PMID: 18181550 Free PMC article.
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: christopher d. 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.
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: christopher d. AAPS PharmSciTech. 2019 Jul 8;20(6):249. doi: 10.1208/s12249-019-1443-7. AAPS PharmSciTech. 2019. PMID: 31286316
355 results