PDUFA VI: It Is Time to Unleash the Full Potential of Model-Informed Drug Development

CPT Pharmacometrics Syst Pharmacol. 2019 Jan;8(1):5-8. doi: 10.1002/psp4.12365. Epub 2018 Nov 29.
No abstract available

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Drug Approval / legislation & jurisprudence*
  • Drug Industry / legislation & jurisprudence
  • Humans
  • Legislation, Drug
  • Models, Theoretical
  • Pharmaceutical Preparations / chemistry*
  • United States
  • United States Food and Drug Administration

Substances

  • Pharmaceutical Preparations