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

Shiew Mei Huang, Darrell R. Abernethy, Yaning Wang, Ping Zhao, Issam Zineh

Research output: Contribution to journalShort surveypeer-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.

Original languageEnglish (US)
Pages (from-to)2912-2923
Number of pages12
JournalJournal of Pharmaceutical Sciences
Volume102
Issue number9
DOIs
StatePublished - Sep 2013

Keywords

  • Dose-response
  • Drug interactions
  • Modeling and simulation
  • PBPK
  • Pharamcokinetics
  • Pharmacodynamics
  • Regulatory science
  • Systems pharmacology

ASJC Scopus subject areas

  • Pharmaceutical Science

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