Healthy Skepticism Library item: 6187

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Publication type: Journal Article

Zhang L, Sinha V, Forgue ST, Callies S, Ni L, Peck R, Allerheiligen SR.
Model-based drug development: the road to quantitative pharmacology.
J Pharmacokinet Pharmacodyn 2006 Jun 01; 33:(3):369-93
http://www.springerlink.com/content/m26kg47q6527m267/

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

Keywords:
Adult Aged Algorithms Antimetabolites, Antineoplastic/administration & dosage Antimetabolites, Antineoplastic/pharmacokinetics Antimetabolites, Antineoplastic/therapeutic use Biological Markers/analysis Biological Markers/metabolism Clinical Trials/methods Clinical Trials/statistics & numerical data Computer Simulation* Decision Making Deoxycytidine/administration & dosage Deoxycytidine/analogs & derivatives Deoxycytidine/pharmacokinetics Deoxycytidine/therapeutic use Dose-Response Relationship, Drug Drug Industry/methods* Drug Industry/statistics & numerical data Drug Industry/trends Female Humans Male Middle Aged Models, Biological* Osteocalcin/blood Osteoporosis, Postmenopausal/blood Osteoporosis, Postmenopausal/drug therapy Pharmacology/methods* Pharmacology/statistics & numerical data Pharmacology/trends Raloxifene/administration & dosage Raloxifene/pharmacokinetics Selective Estrogen Receptor Modulators/administration & dosage Selective Estrogen Receptor Modulators/pharmacokinetics Selective Estrogen Receptor Modulators/therapeutic use Treatment Outcome