title: Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop.
abstract: Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative [1]. Priorities identified included the need for improved modeling and simulation tools, further emphasized in FDA's 2011 Strategic Plan for Regulatory Science [Appendix]. In an effort to support and advance model-informed medical-product development (MIMPD), the Critical Path Institute (C-Path) [www.c-path.org], FDA, and International Society of Pharmacometrics [www.go-isop.org] co-sponsored a workshop in Washington, D.C. on September 26, 2013, to examine integrated approaches to developing and applying model- MIMPD. The workshop brought together an international group of scientists from industry, academia, FDA, and the European Medicines Agency to discuss MIMPD strategies and their applications. A commentary on the proceedings of that workshop is presented here.
authors.affiliation: Clinical Pharmacology, Critical Path Institute, 1730 East River Road, Tucson, AZ, 85718, USA, kromero@c-path.org.
authors.forename: Klaus
authors.initials: K
authors.lastname: Romero
authors.forename: Vikram
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authors.lastname: Sinha
authors.forename: Sandra
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authors.lastname: Allerheiligen
authors.forename: Meindert
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authors.lastname: Pinheiro
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authors.forename: Yaning
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authors.lastname: Wang
authors.forename: Sue-Jane
authors.initials: SJ
authors.lastname: Wang
authors.forename: John-Michael
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authors.lastname: Sauer
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authors.lastname: Rogers
authors.forename: H J
authors.initials: HJ
authors.lastname: Lambers Heerspink
authors.forename: Tawanda
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authors.lastname: Gumbo
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authors.lastname: Vis
authors.forename: Paul
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authors.lastname: Watkins
authors.forename: Tina
authors.initials: T
authors.lastname: Morrison
authors.forename: William
authors.initials: W
authors.lastname: Gillespie
authors.forename: Mark Forrest
authors.initials: MF
authors.lastname: Gordon
authors.forename: Diane
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authors.lastname: Stephenson
authors.forename: Debra
authors.initials: D
authors.lastname: Hanna
authors.forename: Marc
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authors.lastname: Pfister
authors.forename: Richard
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authors.lastname: Lalonde
authors.forename: Thomas
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authors.lastname: Colatsky
mesh_terms: D003198:Computer Simulation; D003657:Decision Making; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D008954:Models, Biological; D008962:Models, Theoretical; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations