title: The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation.
abstract: Advances in predicting in vivo performance of drug products has the potential to change how drug products are developed and reviewed. Modeling and simulation methods are now more commonly used in drug product development and regulatory drug review. These applications include, but are not limited to: the development of biorelevant specifications, the determination of bioequivalence metrics for modified release products with rapid therapeutic onset, the design of in vitro-in vivo correlations in a mechanistic framework, and prediction of food effect. As new regulatory concepts such as quality by design require better application of biopharmaceutical modeling in drug product development, regulatory challenges in bioequivalence demonstration of complex drug products also present exciting opportunities for creative modeling and simulation approaches. A collaborative effort among academia, government and industry in modeling and simulation will result in improved safe and effective new/generic drugs to the American public.
authors.affiliation: Office of Generic Drugs, Food and Drug Administration, United States.
authors.forename: Wenlei
authors.initials: W
authors.lastname: Jiang
authors.forename: Stephanie
authors.initials: S
authors.lastname: Kim
authors.forename: Xinyuan
authors.initials: X
authors.lastname: Zhang
authors.forename: Robert A
authors.initials: RA
authors.lastname: Lionberger
authors.forename: Barbara M
authors.initials: BM
authors.lastname: Davit
authors.forename: Dale P
authors.initials: DP
authors.lastname: Conner
authors.forename: Lawrence X
authors.initials: LX
authors.lastname: Yu
mesh_terms: D003198:Computer Simulation; D004339:Drug Compounding; D016568:Drugs, Generic / Q000737:chemistry / Q000493:pharmacokinetics; D018565:Food-Drug Interactions; D006801:Humans; D004364:Pharmaceutical Preparations / Q000378:metabolism; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic; D004364:Pharmaceutical Preparations