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

J Pharm Sci. 2013 Sep;102(9):2912-23. doi: 10.1002/jps.23570. Epub 2013 May 24.


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.

Keywords: Modeling and simulation; PBPK; dose-response; drug interactions; pharamcokinetics; pharmacodynamics; regulatory science; systems pharmacology.

Publication types

  • Review

MeSH terms

  • Computer Simulation
  • Drug Discovery / legislation & jurisprudence
  • Drug Discovery / methods*
  • Drug Interactions
  • Drug and Narcotic Control*
  • Humans
  • Models, Biological
  • Pharmacokinetics
  • United States
  • United States Food and Drug Administration