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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. 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: adams wp. 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
Bioavailability and bioequivalence: an FDA regulatory overview.
Chen ML, Shah V, Patnaik R, Adams W, Hussain A, Conner D, Mehta M, Malinowski H, Lazor J, Huang SM, Hare D, Lesko L, Sporn D, Williams R. Chen ML, et al. Pharm Res. 2001 Dec;18(12):1645-50. doi: 10.1023/a:1013319408893. Pharm Res. 2001. PMID: 11785681 Review.
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.
153 results