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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: haidar sh. 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.
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