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Use of partial area under the curve metrics to assess bioequivalence of methylphenidate multiphasic modified release formulations.
Stier EM, Davit BM, Chandaroy P, Chen ML, Fourie-Zirkelbach J, Jackson A, Kim S, Lionberger R, Mehta M, Uppoor RS, Wang Y, Yu L, Conner DP. Stier EM, et al. Among authors: lionberger r. AAPS J. 2012 Dec;14(4):925-6. doi: 10.1208/s12248-012-9397-7. Epub 2012 Sep 14. AAPS J. 2012. PMID: 22976173 Free PMC article. 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: lionberger r. 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. 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.
Analysis of bead sizes for MR capsules labeled for sprinkle.
Nagavelli LR, Lionberger RA, Sayeed VA, Yu L, Allgire J, Smith A, Wokovich A, Westenberger BJ, Buhse L. Nagavelli LR, et al. Among authors: lionberger ra. AAPS PharmSciTech. 2010 Dec;11(4):1508-10. doi: 10.1208/s12249-010-9529-2. Epub 2010 Oct 9. AAPS PharmSciTech. 2010. PMID: 20936439 Free PMC article.
79 results