• J Pharm Sci · Sep 2013

    Review

    The utility of modeling and simulation in drug development and regulatory review.

    • Shiew-Mei Huang, Darrell R Abernethy, Yaning Wang, Ping Zhao, and Issam Zineh.
    • 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
    • J Pharm Sci. 2013 Sep 1; 102 (9): 2912-23.

    AbstractUS 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.Published 2013. This article is a U.S. Government work and is in the public domain in the USA.

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