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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.
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: lionberger ra. 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.
79 results