Model-Based Drug Development: The Road to Quantitative Pharmacology.
Zhang, Liping 2; Sinha, Vikram 1; Forgue, S. Thomas 1; Callies, Sophie 1; Ni, Lan 1; Peck, Richard 1; Allerheiligen, Sandra R. B. 1,3
[Article]
Journal of Pharmacokinetics & Pharmacodynamics.
33(3):369-393, July 2006.
(Format: HTML, PDF)
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.
(C)2006 Kluwer Academic Publishers