| Literature DB >> 24048239 |
R Lionberger1, W Jiang, S-M Huang, G Geba.
Abstract
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.Entities:
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Year: 2013 PMID: 24048239 DOI: 10.1038/clpt.2013.104
Source DB: PubMed Journal: Clin Pharmacol Ther ISSN: 0009-9236 Impact factor: 6.875