Document Type

Article

Publication Version

Published Version

Publication Date

9-2011

Journal or Book Title

Clinical Pharmacology and Therapeutics

Volume

90

Issue

3

First Page

467

Last Page

470

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.

Comments

This article is from Clinical Pharmacology & Therapeutics 90 (2011): 467, doi:10.1038/clpt.2011.109. Posted with permission.

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