Pharmacometrics and the transition to model-based development

Clin Pharmacol Ther. 2007 Aug;82(2):137-42. doi: 10.1038/sj.clpt.6100270.

Abstract

As the transition to model-based drug development continues, pharmacometric analysis will have an increasingly important role across the entire life cycle of drug discovery, development, regulatory approval, and commercialization. For this reason, pharmacometrics can--and should--have an integrating function in the transformation to model-based development. This essay describes an approach for formalizing the pharmacometrics process using the disciplines encompassed by enterprise engineering.

Publication types

  • Review

MeSH terms

  • Animals
  • Computer Simulation
  • Drug Approval / methods
  • Drug Approval / statistics & numerical data
  • Drug Design
  • Drug Information Services / statistics & numerical data*
  • Drug Information Services / trends
  • Humans
  • Models, Theoretical*
  • Pharmacology, Clinical / methods
  • Pharmacology, Clinical / statistics & numerical data*
  • Pharmacology, Clinical / trends