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Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report.
Chen ML, Shah VP, Ganes D, Midha KK, Caro J, Nambiar P, Rocci ML Jr, Thombre AG, Abrahamsson B, Conner D, Davit B, Fackler P, Farrell C, Gupta S, Katz R, Mehta M, Preskorn SH, Sanderink G, Stavchansky S, Temple R, Wang Y, Winkle H, Yu L. Chen ML, et al. Among authors: yu l. Clin Ther. 2010 Sep;32(10):1704-12. doi: 10.1016/j.clinthera.2010.09.014. Clin Ther. 2010. PMID: 21194592
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.
The use of BDDCS in classifying the permeability of marketed drugs.
Benet LZ, Amidon GL, Barends DM, Lennernäs H, Polli JE, Shah VP, Stavchansky SA, Yu LX. Benet LZ, et al. Among authors: yu lx. Pharm Res. 2008 Mar;25(3):483-8. doi: 10.1007/s11095-007-9523-x. Epub 2008 Jan 31. Pharm Res. 2008. PMID: 18236138 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.
26,303 results
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