Bioequivalence of oral products and the biopharmaceutics classification system: science, regulation, and public policy

Clin Pharmacol Ther. 2011 Sep;90(3):467-70. doi: 10.1038/clpt.2011.109. Epub 2011 Jul 20.

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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Review

MeSH terms

  • Administration, Oral
  • Biopharmaceutics* / legislation & jurisprudence
  • Biopharmaceutics* / standards
  • Drugs, Generic / pharmacokinetics*
  • Drugs, Generic / standards
  • Humans
  • Pharmaceutical Preparations / standards
  • Policy*
  • Therapeutic Equivalency

Substances

  • Drugs, Generic
  • Pharmaceutical Preparations