title: Equivalence studies for complex active ingredients and dosage forms.
abstract: This article examines the United States Pharmacopeia (USP) and its role in assessing the equivalence and inequivalence of biological and biotechnological drug substances and products-a role USP has played since its founding in 1820. A public monograph in the United States Pharmacopeia-National Formulary helps practitioners and other interested parties understand how an article's strength, quality, and purity should be controlled. Such a monograph is a standard to which all manufactured ingredients and products should conform, and it is a starting point for subsequent-entry manufacturers, recognizing that substantial additional one-time characterization studies may be needed to document equivalence. Review of these studies is the province of the regulatory agency, but compendial tests can provide clarity and guidance in the process.
authors.affiliation: United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, USA.
authors.forename: Lokesh
authors.initials: L
authors.lastname: Bhattycharyya
authors.forename: Roger
authors.initials: R
authors.lastname: Dabbah
authors.forename: Walter
authors.initials: W
authors.lastname: Hauck
authors.forename: Eric
authors.initials: E
authors.lastname: Sheinin
authors.forename: Lynn
authors.initials: L
authors.lastname: Yeoman
authors.forename: Roger
authors.initials: R
authors.lastname: Williams
mesh_terms: D001709:Biotechnology / Q000379:methods / Q000592:standards; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards; D004304:Dosage Forms / Q000592:standards*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000378:metabolism / Q000592:standards*; D010602:Pharmacopoeias as Topic / Q000592:standards*; D012015:Reference Standards; D013810:Therapeutic Equivalency; D014481:United States
chemical_list: D004304:Dosage Forms; D004364:Pharmaceutical Preparations