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Model-Based Drug Development: The Road to Quantitative Pharmacology

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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.

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Authors and Affiliations

  1. Drug Disposition and Global PK/PD, Lilly Research Laboratories, Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN, 46285, USA

    Vikram Sinha, S. Thomas Forgue, Sophie Callies, Lan Ni, Richard Peck & Sandra R. B. Allerheiligen

  2. Bristol Myers-Squibb, Princeton, New Jersey

    Liping Zhang

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  1. Liping Zhang
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  2. Vikram Sinha
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  3. S. Thomas Forgue
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  4. Sophie Callies
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  5. Lan Ni
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  6. Richard Peck
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  7. Sandra R. B. Allerheiligen
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Correspondence to Sandra R. B. Allerheiligen.

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Zhang, L., Sinha, V., Forgue, S.T. et al. Model-Based Drug Development: The Road to Quantitative Pharmacology. J Pharmacokinet Pharmacodyn 33, 369–393 (2006). https://doi.org/10.1007/s10928-006-9010-8

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  • DOI: https://doi.org/10.1007/s10928-006-9010-8

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