Model Evaluation of Continuous Data Pharmacometric Models: Metrics and Graphics.

T H T Nguyen, M-S Mouksassi, N Holford, N Al-Huniti, I Freedman, A C Hooker, J John, M O Karlsson, D R Mould, J J P��rez Ruixo, E L Plan, R Savic, J G C van Hasselt, B Weber, C Zhou, E Comets, F Mentr��, Model Evaluation Group of the International Society of Pharmacometrics (ISoP) Best Practice Committee
Author Information
  1. T H T Nguyen: INSERM, IAME, UMR 1137, Paris, France, Universit�� Paris Diderot, Sorbonne Paris Cit��, Paris, France.
  2. M-S Mouksassi: Certara Strategic Consulting, Montr��al, Canada.
  3. N Holford: Department of Pharmacology and Clinical Pharmacology, University of Auckland, Auckland, New Zealand.
  4. N Al-Huniti: Quantitative Clinical Pharmacology, AstraZeneca, Waltham, Massachusetts, USA.
  5. I Freedman: Dr Immanuel Freedman Inc., Harleysville, Pennsylvania, USA.
  6. A C Hooker: Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
  7. J John: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC, USA.
  8. M O Karlsson: Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
  9. D R Mould: Projections Research Inc., Phoenixville, Pennsylvania, USA.
  10. J J P��rez Ruixo: The Janssen Pharmaceutical Companies of Johnson & Johnson, Belgium.
  11. E L Plan: Pharmetheus, Uppsala, Sweden.
  12. R Savic: Department of Bioengineering and Therapeutic Sciences, University of California - San Francisco, San Francisco, California, USA.
  13. J G C van Hasselt: Division of Pharmacology, Leiden Academic Centre for Drug Research, Leiden University, Leiden, Netherlands.
  14. B Weber: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA.
  15. C Zhou: Genentech, San Francisco, California, USA.
  16. E Comets: INSERM, IAME, UMR 1137, Paris, France, Universit�� Paris Diderot, Sorbonne Paris Cit��, Paris, France.
  17. F Mentr��: INSERM, IAME, UMR 1137, Paris, France, Universit�� Paris Diderot, Sorbonne Paris Cit��, Paris, France.

Abstract

This article represents the first in a series of tutorials on model evaluation in nonlinear mixed effect models (NLMEMs), from the International Society of Pharmacometrics (ISoP) Model Evaluation Group. Numerous tools are available for evaluation of NLMEM, with a particular emphasis on visual assessment. This first basic tutorial focuses on presenting graphical evaluation tools of NLMEM for continuous data. It illustrates graphs for correct or misspecified models, discusses their pros and cons, and recalls the definition of metrics used.

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MeSH Term

Female
Humans
Male
Models, Biological
Nonlinear Dynamics
Pharmacokinetics
Warfarin

Chemicals

Warfarin

Word Cloud

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