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Bioequivalence of Oral Products and the Biopharmaceutics Classification System: Science, Regulation, and Public Policy
Author(s) -
Amidon K S,
Langguth P,
Lennernäs H,
Yu L,
Amidon G L
Publication year - 2011
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.2011.109
Subject(s) - bioequivalence , biopharmaceutics , biopharmaceutics classification system , innovator , clinical pharmacology , pharmacology , formulary , product (mathematics) , medicine , computer science , business , pharmacokinetics , management science , mathematics , chemistry , economics , intellectual property , pharmacognosy , biochemistry , geometry , biological activity , in vitro , operating system
The demonstration of bioequivalence (BE) is an essential requirement for ensuring that patients receive a product that performs as indicated by the label. The BE standard for a particular product is set by its innovator, and this standard must subsequently be matched by generic drug products. The Biopharmaceutics Classification System (BCS) sets a scientific basis for an improved BE standard for immediate‐release solid oral dosage forms. In this paper, we discuss BE and the BCS, as well as the issues that are currently relevant to BE as a pharmaceutical product standard. Clinical Pharmacology & Therapeutics (2011) 90 3, 467–470. doi: 10.1038/clpt.2011.109