Article
Bioequivalence of Oral Products and the Biopharmaceutics Classification System: Science, Regulation, and Public Policy
Clinical Pharmacology and Therapeutics
Document Type
Article
Disciplines
Publication Version
Published Version
Publication Date
9-1-2011
DOI
10.1038/clpt.2011.109
Abstract
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.
Rights
Works produced by employees of the U.S. Government as part of their official duties are not copyrighted within the U.S. The content of this document is not copyrighted.
Language
en
File Format
application/pdf
Citation Information
Kevin S Amidon, P. Langguth, H. Lennernas, L. Yu, et al.. "Bioequivalence of Oral Products and the Biopharmaceutics Classification System: Science, Regulation, and Public Policy" Clinical Pharmacology and Therapeutics Vol. 90 Iss. 3 (2011) p. 467 - 470 Available at: http://works.bepress.com/kevin_amidon/7/
This article is from Clinical Pharmacology & Therapeutics 90 (2011): 467, doi:10.1038/clpt.2011.109. Posted with permission.