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U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

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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.

Category: Journal Article, Editorial
PubMed ID: #24048239 DOI: 10.1038/clpt.2013.104
Includes FDA Authors from Scientific Area(s): Drugs
Entry Created: 2013-09-21 Entry Last Modified: 2013-10-26