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Confidence in Generic Drug Substitution
Author(s) -
Lionberger R,
Jiang W,
Huang SM,
Geba G
Publication year - 2013
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2013.104
Subject(s) - bioequivalence , drug , food and drug administration , substitution (logic) , generic drug , pharmacology , clinical pharmacology , product (mathematics) , confidence interval , medicine , risk analysis (engineering) , computer science , pharmacokinetics , mathematics , geometry , programming language
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. Clinical Pharmacology & Therapeutics (2013); 94 4, 438–440. doi: 10.1038/clpt.2013.104