Pharmacokinetic/Pharmacodynamic Modeling and Simulations in Drug Development

Authored by: Dawei Xuan , Sally Y. Choe

Encyclopedia of Pharmaceutical Science and Technology

Print publication date:  July  2013
Online publication date:  July  2013

Print ISBN: 9781841848198
eBook ISBN: 9781351124874
Adobe ISBN:


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With each passing year, the pharmaceutical industry faces an increasing number of challenges. The drug industry continues to consolidate and become more competitive (1). Highly publicized lawsuits have heightened sensitivities with respect to the balance between acceptable efficacy and safety. The U.S. Food and Drug Administration (FDA) reports that about 22% of the drugs had labeling changes after approval, most of which were safety-motivated and net dosage decreases (24). In addition, the industry has been struggling to increase productivity despite the advancement of basic research (5). In light of all these issues and the ever-increasing cost of drug development ($800 million/yr (6)), the pharmaceutical industry is increasingly focusing on ways to streamline the drug development process through more efficiently designed clinical trials. Pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation, which generally have not been in wide use in drug development in the past, are useful and important tools that can improve the efficiency of the drug development process, from preclinical stage to the postmarketing phase and beyond.

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