title: Bioavailability and bioequivalence: an FDA regulatory overview.
abstract: Bioavailability and/or bioequivalence studies play a key role in the drug development period for both new drug products and their generic equivalents. For both, these studies are also important in the postapproval period in the presence of certain manufacturing changes. Like many regulatory studies, the assessment of bioavailability and bioequivalence can generally be achieved by considering the following three questions. What is the primary question of the study? What are the tests that can be used to address the question? What degree of confidence is needed for the test outcome? This article reviews the regulatory science of bioavailability and bioequivalence and provides FDA's recommendations for drug sponsors who intend to establish bioavailability and/or demonstrate bioequivalence for their pharmaceutical products during the developmental process or after approval.
authors.affiliation: Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA. chenme@cder.fda.gov
authors.forename: M L
authors.initials: ML
authors.lastname: Chen
authors.forename: V
authors.initials: V
authors.lastname: Shah
authors.forename: R
authors.initials: R
authors.lastname: Patnaik
authors.forename: W
authors.initials: W
authors.lastname: Adams
authors.forename: A
authors.initials: A
authors.lastname: Hussain
authors.forename: D
authors.initials: D
authors.lastname: Conner
authors.forename: M
authors.initials: M
authors.lastname: Mehta
authors.forename: H
authors.initials: H
authors.lastname: Malinowski
authors.forename: J
authors.initials: J
authors.lastname: Lazor
authors.forename: S M
authors.initials: SM
authors.lastname: Huang
authors.forename: D
authors.initials: D
authors.lastname: Hare
authors.forename: L
authors.initials: L
authors.lastname: Lesko
authors.forename: D
authors.initials: D
authors.lastname: Sporn
authors.forename: R
authors.initials: R
authors.lastname: Williams
mesh_terms: D001682:Biological Availability; D017277:Drug Approval; D016568:Drugs, Generic; D015507:Drugs, Investigational; D007880:Legislation, Drug; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic; D015507:Drugs, Investigational