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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: conner dp. 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
Bioequivalence approaches for highly variable drugs and drug products.
Haidar SH, Davit B, Chen ML, Conner D, Lee L, Li QH, Lionberger R, Makhlouf F, Patel D, Schuirmann DJ, Yu LX. Haidar SH, et al. Pharm Res. 2008 Jan;25(1):237-41. doi: 10.1007/s11095-007-9434-x. Epub 2007 Sep 22. Pharm Res. 2008. PMID: 17891552 Review.
Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.
Davit BM, Chen ML, Conner DP, Haidar SH, Kim S, Lee CH, Lionberger RA, Makhlouf FT, Nwakama PE, Patel DT, Schuirmann DJ, Yu LX. Davit BM, et al. Among authors: conner dp. AAPS J. 2012 Dec;14(4):915-24. doi: 10.1208/s12248-012-9406-x. Epub 2012 Sep 13. AAPS J. 2012. PMID: 22972221 Free PMC article. Review.
Novel bioequivalence approach for narrow therapeutic index drugs.
Yu LX, Jiang W, Zhang X, Lionberger R, Makhlouf F, Schuirmann DJ, Muldowney L, Chen ML, Davit B, Conner D, Woodcock J. Yu LX, et al. Clin Pharmacol Ther. 2015 Mar;97(3):286-91. doi: 10.1002/cpt.28. Epub 2014 Dec 15. Clin Pharmacol Ther. 2015. PMID: 25669762
61 results