Bioequivalence of Oral Products and the Biopharmaceutics Classification System: Science, Regulation, and Public Policy

Date
2011-09-01
Authors
Amidon, Kevin
Langguth, P.
Lennernas, H.
Yu, L.
Amidon, G.L.
Major Professor
Advisor
Committee Member
Journal Title
Journal ISSN
Volume Title
Publisher
Altmetrics
Authors
Research Projects
Organizational Units
World Languages and Cultures
Organizational Unit
Journal Issue
Series
Department
World Languages and Cultures
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.

Description
Keywords
Citation
DOI
Collections