Model-Based Drug Development: The Road to Quantitative Pharmacology |
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Authors: | Liping Zhang Vikram Sinha S. Thomas Forgue Sophie Callies Lan Ni Richard Peck Sandra R. B. Allerheiligen |
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Affiliation: | (1) Drug Disposition and Global PK/PD, Lilly Research Laboratories, Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, USA;(2) Bristol Myers-Squibb, Princeton, New Jersey |
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Abstract: | 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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Keywords: | model-based drug development quantitative pharmacology disease model drug exposure-response model knowledge management decision making gemcitabine raloxifene |
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