title: The utility of modeling and simulation in drug development and regulatory review.
abstract: US Food and Drug Administration (FDA) has identified innovation in clinical evaluations as a major scientific priority area. This paper provides case studies and updates to describe the efforts by the FDA's Office of Clinical Pharmacology in its development and application of regulatory science, focusing on modeling and simulation. Key issues and challenges are identified that need to be addressed to promote the uptake of modeling and simulation approaches in drug regulation. Published 2013. This article is a U.S. Government work and is in the public domain in the USA. 102:2912-2923, 2013.
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. ShiewMei.Huang@FDA.HHS.GOV
authors.forename: Shiew-Mei
authors.initials: SM
authors.lastname: Huang
authors.forename: Darrell R
authors.initials: DR
authors.lastname: Abernethy
authors.forename: Yaning
authors.initials: Y
authors.lastname: Wang
authors.forename: Ping
authors.initials: P
authors.lastname: Zhao
authors.forename: Issam
authors.initials: I
authors.lastname: Zineh
mesh_terms: D003198:Computer Simulation; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000379:methods*; D004347:Drug Interactions; D004335:Drug and Narcotic Control; D006801:Humans; D008954:Models, Biological; D010599:Pharmacokinetics; D014481:United States; D014486:United States Food and Drug Administration
keywords: Modeling and simulation; PBPK; dose-response; drug interactions; pharamcokinetics; pharmacodynamics; regulatory science; systems pharmacology