title: Modeling and simulation of biopharmaceutical performance.
abstract: Biopharmaceutical performance refers to the influence of pharmaceutical formulation variables on in vivo performance. New drug product success depends on formulation design for sufficient bioavailability for clinically desired dosing. Regulatory interest in biopharmaceutical performance includes batch-to-batch consistency, acceptability of postapproval changes, and evaluation of bioequivalence (BE) for generic drug products. This Commentary summarizes biopharmaceutical modeling and simulation in the US Food and Drug Administration (FDA) Office of Generic Drugs (OGD) for orally administered generic drugs.
authors.affiliation: Office of Generic Drugs, US Food and Drug Administration, Rockville, Maryland, USA.
authors.forename: X
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Office of Generic Drugs, US Food and Drug Administration, Rockville, Maryland, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Lionberger
mesh_terms: D000284:Administration, Oral; D001682:Biological Availability; D003198:Computer Simulation; D017277:Drug Approval; D015195:Drug Design; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000493:pharmacokinetics; D006801:Humans; D008954:Models, Biological; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic; D004364:Pharmaceutical Preparations