Scientific Publications by FDA Staff

Clin Pharmacol Ther 2013 Oct;94(4):438-40

Confidence in generic drug substitution.

Lionberger R, Jiang W, Huang SM, Geba G

Patients should have confidence that the generic drugs they are prescribed in the United States can be effectively substituted for the brand product or another generic product. Through new bioequivalence study designs for narrow therapeutic index (NTI) drugs and postapproval studies of generic substitution, the US Food and Drug Administration's (FDA's) ongoing generic drug regulatory science activities are designed to ensure successful generic substitution for all drug products.