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Model-Based Drug Development: The Road to Quantitative Pharmacology

  • Liping Zhang
  • Vikram Sinha
  • S. Thomas Forgue
  • Sophie Callies
  • Lan Ni
  • Richard Peck
  • Sandra R. B. AllerheiligenEmail author
Article

High development costs and low success rates in bringing new medicines to the market demand more efficient and effective approaches. Identified by the FDA as a valuable prognostic tool for fulfilling such a demand, model-based drug development is a mathematical and statistical approach that constructs, validates, and utilizes disease models, drug exposure-response models, and pharmacometric models to facilitate drug development. Quantitative pharmacology is a discipline that learns and confirms the key characteristics of new molecular entities in a quantitative manner, with goal of providing explicit, reproducible, and predictive evidence for optimizing drug development plans and enabling critical decision making. Model-based drug development serves as an integral part of quantitative pharmacology. This work reviews the general concept, basic elements, and evolving role of model-based drug development in quantitative pharmacology. Two case studies are presented to illustrate how the model-based drug development approach can facilitate knowledge management and decision making during drug development. The case studies also highlight the organizational learning that comes through implementation of quantitative pharmacology as a discipline. Finally, the prospects of quantitative pharmacology as an emerging discipline are discussed. Advances in this discipline will require continued collaboration between academia, industry and regulatory agencies.

Keywords

model-based drug development quantitative pharmacology disease model drug exposure-response model knowledge management decision making gemcitabine raloxifene 

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Copyright information

© Springer Science+Business Media, Inc. 2006

Authors and Affiliations

  • Liping Zhang
    • 2
  • Vikram Sinha
    • 1
  • S. Thomas Forgue
    • 1
  • Sophie Callies
    • 1
  • Lan Ni
    • 1
  • Richard Peck
    • 1
  • Sandra R. B. Allerheiligen
    • 1
    Email author
  1. 1.Drug Disposition and Global PK/PD, Lilly Research LaboratoriesEli Lilly & Co., Lilly Corporate CenterIndianapolisUSA
  2. 2.Bristol Myers-SquibbPrincetonNew Jersey

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