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Curr Pharmacol Rep. 2016 Oct;2(5):221-230. doi: 10.1007/s40495-016-0066-x. Epub 2016 Aug 15.

Disease Progression Modeling: Key Concepts and Recent Developments.

Current pharmacology reports

Sarah F Cook, Robert R Bies

Affiliations

  1. Department of Pharmaceutical Sciences, University at Buffalo, State University of New York, 445 Kapoor Hall, Buffalo, NY 14214, USA.
  2. Department of Pharmacology and Therapeutics, Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY 14263, USA.
  3. Centre for Addiction and Mental Health, University of Toronto, 1001 Queen Street West, Toronto, ON M6J 1H4, Canada.

PMID: 28936389 PMCID: PMC5602534 DOI: 10.1007/s40495-016-0066-x

Abstract

Disease modeling involves the use of mathematical functions to describe quantitatively the time course of disease progression. In order to characterize the natural progression of disease, these models generally incorporate longitudinal data for some biomarker(s) of disease severity or can incorporate more direct measures of disease severity. Disease models are also often linked to pharmacokinetic-pharmacodynamic models so that the influence of drug treatment on disease progression can be quantified and evaluated. Regulatory agencies have embraced disease progression models as powerful tools that can be used to improve drug development productivity. This article provides a brief overview of key concepts in disease progression modeling followed by illustrative examples from models for Alzheimer's disease. Finally, recent novel applications in which disease progression models have been linked to cost-effectiveness analysis and genomic analysis are described.

Keywords: clinical pharmacology; disease progression; drug development; modeling and simulation; pharmacometrics

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