6MEREDITH P. Bioequivalence and other unresolved issues in ge-neric drug substitution [ J ]. Clin Ther,2003 , 25 ( 11 ) : 2875 -2890.
7LEVIN AA. Generics,efficacy confirmed [ N ] . Health Facts,1990 - 10 -01.
8KARKI L. Review of FDA law related to pharmaceuticals: theHatch-Waxman Act, regulatory amendments and implications fordrug patent enforcement[ J]. J Pat Trade Off Soc,2005 ,87(1):602 -620.