title: Bioavailability and Bioequivalence Aspects of Oral Modified-Release Drug Products.
abstract: Oral modified-release (MR) products are dosage forms administered through the mouth and designed to release drug in a controlled manner to achieve maximum efficacy, minimal side effects, and better patient compliance. With significant progress in pharmaceutical technologies and favored therapeutic benefit, more and more oral MR products including the generic versions of these products are being developed, marketed, and used in the USA. Because different types of MR products may exhibit unique drug release modes and specific pharmacokinetic profiles, a better understanding of the regulation and evaluation of these generic MR products can help development and marketing of generic MR products that are therapeutically equivalent to the corresponding reference product. This review summarizes the general regulatory requirements for establishing bioequivalence between generic and reference oral MR products. In addition, some special regulatory considerations for bioequivalence evaluation are highlighted with examples of specific oral MR drug products.
authors.affiliation: Division of Bioequivalence I, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Rong
authors.initials: R
authors.lastname: Wang
authors.affiliation: Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Dale P
authors.initials: DP
authors.lastname: Conner
authors.affiliation: Division of Bioequivalence I, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. bing.li@fda.hhs.gov.
authors.forename: Bing V
authors.initials: BV
authors.lastname: Li
mesh_terms: D000284:Administration, Oral; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D003692:Delayed-Action Preparations; D015195:Drug Design; D065546:Drug Liberation; D004335:Drug and Narcotic Control; D016568:Drugs, Generic / Q000008:administration & dosage / Q000493:pharmacokinetics; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000378:metabolism; D013810:Therapeutic Equivalency; D014481:United States
chemical_list: D003692:Delayed-Action Preparations; D016568:Drugs, Generic; D004364:Pharmaceutical Preparations
keywords: bioavailability; bioequivalence; modified release; oral dosage form