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Clinical Trial Simulations pp 37–57Cite as

Contribution of Modeling and Simulation in the Regulatory Review and Decision-Making: U.S. FDA Perspective

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Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 1))

Abstract

The Division of Pharmacometrics at the U.S. FDA engages in regulatory reviews, research and policy development. During 2000–2008, over 50% of pharmacometric reviews of 198 NDA and BLA applications influenced approval and safety decisions. During this time, pharmacometric analyses were used in pediatric dose selection, and approval of doses not directly studied in effectiveness trials. Additionally, pharmacometrics has been used in FDA advice on protocol design to optimize dosing regimens based on benefit-risk for clinical testing, and to provide confirmatory evidence of effectiveness. Current research projects aim to solve drug development challenges and develop policies grounded in pharmacometric principles and methodologies.

The opinions and information in this review article are those of the authors, and do not represent the views and/or policies of the U.S. Food and Drug Administration.

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Authors and Affiliations

  1. Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    Christine E. Garnett

Authors
  1. Christine E. Garnett
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  2. Joo Yeon Lee
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  3. Jogarao V. S. Gobburu
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Corresponding author

Correspondence to Christine E. Garnett .

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Editors and Affiliations

  1. Department of Advanced Modeling & Simula, Janssen Research & Development, LLC, Route 202 S. 920, Raritan, 08869, New Jersey, USA

    Holly H. C. Kimko

  2. Dept. Biopharmaceutical Sciences, University of California, San Francisco, Parnassus Ave. 513, San Francisco, 94143-0446, California, USA

    Carl C. Peck

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Garnett, C.E., Lee, J.Y., Gobburu, J.V.S. (2011). Contribution of Modeling and Simulation in the Regulatory Review and Decision-Making: U.S. FDA Perspective. In: Kimko, H., Peck, C. (eds) Clinical Trial Simulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 1. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-7415-0_3

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