title: Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products.
abstract: For ophthalmic drug products, the determination of bioequivalence can be challenging, as drug concentrations at the site of action cannot always be measured. The FDA has recommended a variety of studies that can be used to demonstrate bioequivalence for different ophthalmic drug products. Product-specific bioequivalence recommendations for 28 ophthalmic products have been posted on FDA's website as of May 2016, outlining the specific tests which should be performed to demonstrate bioequivalence. The type of study that can be used to demonstrate bioequivalence depends on the drug product's active pharmaceutical ingredient(s), dosage form, indication, site of action, mechanism of action, and scientific understanding of drug release/drug availability and drug product characteristics. This article outlines the FDA's current guidance on studies to demonstrate bioequivalence through clinical endpoint studies, pharmacokinetic studies, and in vitro studies for generic ophthalmic drug products.
authors.affiliation: Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland, 20993, USA. Stephanie.Choi@fda.hhs.gov.
authors.forename: Stephanie H
authors.initials: SH
authors.lastname: Choi
authors.affiliation: Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland, 20993, USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Lionberger
mesh_terms: D060433:Administration, Ophthalmic; D000818:Animals; D001082:Aqueous Humor / Q000187:drug effects / Q000378:metabolism*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D005128:Eye Diseases / Q000188:drug therapy* / Q000378:metabolism*; D006801:Humans; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D016568:Drugs, Generic
keywords: bioequivalence; drug release; generic drugs; ophthalmic drugs; physicochemical characterization