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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: yu l. 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
Summary workshop report: biopharmaceutics classification system--implementation challenges and extension opportunities.
Polli JE, Yu LX, Cook JA, Amidon GL, Borchardt RT, Burnside BA, Burton PS, Chen ML, Conner DP, Faustino PJ, Hawi AA, Hussain AS, Joshi HN, Kwei G, Lee VH, Lesko LJ, Lipper RA, Loper AE, Nerurkar SG, Polli JW, Sanvordeker DR, Taneja R, Uppoor RS, Vattikonda CS, Wilding I, Zhang G. Polli JE, et al. Among authors: yu lx. J Pharm Sci. 2004 Jun;93(6):1375-81. doi: 10.1002/jps.20064. J Pharm Sci. 2004. PMID: 15124197 No abstract available.
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. Among authors: yu lx. 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.
Quality by design: concepts for ANDAs.
Lionberger RA, Lee SL, Lee L, Raw A, Yu LX. Lionberger RA, et al. Among authors: yu lx. AAPS J. 2008 Jun;10(2):268-76. doi: 10.1208/s12248-008-9026-7. Epub 2008 May 9. AAPS J. 2008. PMID: 18465252 Free PMC article.
Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond.
Polli JE, Abrahamsson BS, Yu LX, Amidon GL, Baldoni JM, Cook JA, Fackler P, Hartauer K, Johnston G, Krill SL, Lipper RA, Malick WA, Shah VP, Sun D, Winkle HN, Wu Y, Zhang H. Polli JE, et al. Among authors: yu lx. AAPS J. 2008 Jun;10(2):373-9. doi: 10.1208/s12248-008-9040-9. Epub 2008 Aug 5. AAPS J. 2008. PMID: 18679807 Free PMC article.
24,350 results
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